Siemens Healthcare Diagnostics
FDA 510(k) medical device clearances.
Top product codes for Siemens Healthcare Diagnostics
Recent clearances by Siemens Healthcare Diagnostics
- K243570 — Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)
- K162977 — ADVIA 2120i, ADVIA 2120
- K162298 — LOCI Total Vitamin D Total Assay, LOCI VITD CAL
- K161954 — Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)
- K162538 — ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
- K151964 — Xprecia Stride Coagulation System, Xprecia System PT Controls
- K150168 — Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)
- K143720 — Dimension Vista MMB Assay
- K140790 — Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
- K150132 — IMMULITE IGF Control Module, IMMULITE Gastrin Control Module
- K143639 — IMMULITE 2000 CEA Calibration Verification Material
- K140717 — CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT
- K133512 — LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)
- K122539 — MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM
- K130698 — DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)
- K121981 — ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY
- K123677 — DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)
- K123320 — DIMENSION AMMONIA FLEX REAGENT CARTRIDGE
- K123321 — DIMENSION CHEMISTRY III CALIBRATORY
- K122323 — DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI
- K121907 — DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR
- K113216 — RAPIDPOINT 500 BLOOD GAS ANALYER
- K102644 — ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I
- K112999 — DIMENSION CLINICAL CHEMISTRY SYSTEM
- K112142 — DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE
- K110061 — CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL
- K110934 — ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY
- K110277 — RAPIDPOINT 405 NEONATAL BILIRUBIN
- K101572 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
- K110303 — STRATUS CS ACUTE CARE D-DIMER
- K102510 — DIMENSIONS HB1C KIT, MODEL DF105A
- K103683 — IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)
- K100344 — DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605
- K100321 — DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604
- K110169 — DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H
- K101854 — ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429
- K093626 — INNOVANCE D-DIMER, MODEL OPBP09
- K102904 — ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL
- K093107 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
- K101425 — MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES
- K100200 — ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138
- K090346 — ADVIA 2120/2120I BODY FLUIDS
- K101460 — LOCI 8 CALIBRATOR, MODEL KC 646
- K093939 — ADVIA CHEMISTRY SALICYLATE REAGENT
- K100433 — IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,
- K100289 — ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781
- K100778 — DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A
- K093441 — DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435
- K093732 — ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770
- K093645 — EXL ANEM CAL, MODEL RC640
- K093631 — B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644
- K091949 — MICROSCAN MICROSTREP PLUS, MODEL B1027-201
- K091867 — ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773
- K091361 — IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM
- K092993 — ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL
- K091916 — INNOVANCE D-DIMER, MODEL OPBP09
- K092919 — MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025
- K092283 — DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG
- K091216 — CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797
- K091123 — ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS
- K091289 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
- K091264 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017
- K090900 — ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771
- K081769 — INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5
- K090257 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
- K083844 — ADVIA CENTAUR TSH3-ULTRA METHOD
- K090594 — DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID
- K090236 — DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454
- K083386 — ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)
- K083487 — EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR
- K083445 — N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC
- K083853 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
- K083463 — DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M
- K083314 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
- K083906 — ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487
- K083462 — DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350
- K083465 — DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE
- K083579 — DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360
- K083262 — MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML)
- K083159 — BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2
- K083175 — BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2
- K082503 — DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL
- K071474 — DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426
- K081732 — INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS
- K082680 — LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623
- K082645 — DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623
- K081013 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN
- K081731 — DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32
- K080167 — ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS
- K081683 — LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621
- K081643 — DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692
- K081300 — DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE
Data sourced from openFDA. This site is unofficial and independent of the FDA.