Siemens Healthcare Diagnostics, Inc.
FDA 510(k) medical device clearances.
Top product codes for Siemens Healthcare Diagnostics, Inc.
Recent clearances by Siemens Healthcare Diagnostics, Inc.
1–100 of 152- K251998 — Atellica CH Diazo Total Bilirubin (D_TBil)
- K251543 — Atellica® IM TSH3-Ultra II (TSH3ULII)
- K251630 — Atellica IM Total PSA II (tPSAII)
- K250816 — ADVIA Centaur Anti-Thyroglobulin II (aTgII)
- K250250 — ADVIA Centaur Anti-Thyroid Peroxidase II
- K242981 — Atellica IM Thyroglobulin (Tg)
- K242685 — Atellica® CH Creatinine_3 (Crea3)
- K241800 — Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)
- K241165 — Atellica® IM High-Sensitivity Troponin I (TnIH)
- K233050 — ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
- K233242 — Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)
- K220265 — ADVIA Centaur® NT-proBNPII (PBNPII)
- K222439 — Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
- K221605 — Emit® II Plus Buprenorphine Assay
- K222438 — A-LYTE® Integrated Multisensor (IMT Na K Cl)
- K222116 — Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)
- K223078 — Atellica® CH Diazo Direct Bilirubin (D_DBil)
- K221801 — ADVIA Centaur® Anti-Müllerian Hormone (AMH)
- K222104 — Atellica® CH Diazo Total Bilirubin (D_TBil)
- K221119 — RCRP Flex reagent cartridge
- K220262 — Dimension EXL LOCI BRAHMS Procalcitonin (PCT)
- K212223 — Atellica CH Enzymatic Creatinine_3 (ECre3)
- DEN190056 — ADVIA Centaur Enhanced Liver Fibrosis (ELF)
- K193397 — ADVIA Centaur® Digoxin assay
- K200210 — ADVIA Centaur® Total hCG assay
- K200256 — ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay
- K200509 — ADVIA Centaur Vitamin D Total (VitD)
- K200199 — ADVIA Centaur CA 125II
- K192240 — RAPIDPoint 500e Blood Gas System
- K193489 — ADVIA Centaur BR
- K193493 — ADVIA Centaur Total IgE (tIgE)
- K192788 — ADVIA Centaur Cortisol (COR)
- K192777 — ADVIA Centaur CA 15-3 assay
- K192790 — Atellica IM Total hCG (ThCG)
- K191533 — ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG
- K191454 — Atellica CH Amylase_2 (AMY_2)
- K191578 — ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control
- K190675 — Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
- K182225 — Dimension Vista High-Sensitivity Troponin I (TNIH) Assay
- K181213 — ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control
- K171566 — Atellica IM High-Sensitivity Troponin I (TNIH)
- K181002 — Atellica IM BRAHMS Procalcitonin (PCT)
- K173909 — Dimension Hemoglobin A1c Assay
- K171274 — ADVIA Centaur High-Sensitivity Troponin I (TNIH)
- K181082 — ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)
- K172201 — Atellica IM Folate Assay
- K172322 — Atellica IM Total hCG (ThCG)
- K171771 — ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
- K170293 — Emit II Plus Cocaine Metabolite Assay
- K172910 — Emit II Plus Oxycodone Assay
- K171642 — Atellica IM Ferritin Assay
- K163658 — ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay
- K163220 — Atellica CH Phencyclidine (Pcp)
- K170065 — ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)
- K162399 — Atellica CH Magnesium (Mg)
- K161494 — Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)
- K161964 — ADVIA Centaur HAV IgM Assay
- K160724 — ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator
- K151986 — ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material
- K160647 — IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4
- K160202 — Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
- K152061 — IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material
- K151529 — Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator
- K142826 — ADVIA Centaur Toxoplasma M (Toxo M)
- K153365 — ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator
- K151767 — Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator
- K151792 — Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System
- K150606 — Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive
- K143687 — ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material
- K150039 — MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)
- K150403 — ADVIA Centaur TSH3-Ultra
- K141999 — ADVIA CENTAUR TSH
- K142723 — ADVIA Centaur Cortisol (COR) Assy
- K143373 — IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material
- K143636 — IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material
- K143680 — ADVIA Centaur IgE Master Curve Material
- K143504 — IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material
- K143352 — IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material
- K143376 — ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material
- K142758 — ADVIA Centaur HAV total assay
- K143194 — ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM)
- K140842 — DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART
- K140859 — DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT
- K142878 — IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material
- K142811 — IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM)
- K142864 — ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM)
- K141772 — IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL
- K133156 — ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY;ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIA
- K141444 — IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL
- K133816 — IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL
- K132801 — IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY
- K140818 — IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN C
- K140541 — IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C
- K140505 — ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL
- K140267 — ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM)
- K140258 — IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH CALIBRATION VERIFICATION MATERIAL
- K133491 — ADVIA CENTAUR TESTOSTERONE (TSTO)
- K133601 — ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY
- K132638 — DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE
- K131307 — ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.