Beckman Coulter, Inc.
FDA 510(k) medical device clearances.
Top product codes for Beckman Coulter, Inc.
Recent clearances by Beckman Coulter, Inc.
1–100 of 270- K252169 — Access BNP II
- K254059 — Access anti-HBc IgM
- K253687 — Access anti-HBc Total
- K251995 — Access anti-HAV IgM
- K250588 — Access Rubella IgG
- K252580 — iQ200 Series
- K243846 — Access anti-HAV
- K243804 — MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)
- K250036 — MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)
- K243483 — Access hsTnI
- K250084 — MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)
- K242870 — Access hsTnI
- K242022 — Access Toxo IgG
- K242190 — Access Cortisol; DxC 500i Clinical Analyzer
- K242095 — Access Toxo IgM II
- K241427 — Access Syphilis
- K240469 — Access TPO Antibody
- K240252 — UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System
- K240987 — Access sTfR
- K240996 — Access Thyroglobulin Antibody II
- K240927 — Access Thyroglobulin
- K241423 — Access Thyroglobulin
- K240479 — Access OV Monitor
- K240403 — Access BR Monitor
- K240800 — Access Intrinsic Factor Ab
- K240182 — Access EPO
- K232164 — Access NT-proBNP
- K234052 — Access Ferritin
- K240273 — Access Free T4
- K232791 — Access Intact PTH
- K234005 — Access CK-MB
- K233480 — Access SHBG
- K222881 — Access hsTnI
- K230648 — Access hsTnI
- K232600 — DxFLEX Flow Cytometer; ClearLLab 10C Panels
- K213517 — Access Thyroglobulin Antibody II
- K223921 — Access CEA
- K231832 — Access Myoglobin
- K220972 — Access Thyroglobulin
- K223590 — Access Folate Assay
- K222996 — Access PCT
- K221493 — MicroScan Prompt Inoculation System-D
- K223038 — Access Cortisol
- K223679 — Access AMH
- K223503 — Access 25(OH) Vitamin D Total
- K223405 — Access Testosterone
- K221990 — Access Total ßhCG (5th IS)
- K223289 — Access Vitamin B12
- K221225 — Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
- K220178 — Total Immunoglobulin E (IgE)
- K210127 — iQ200 System, iChemVELOCITY Automated Urine Chemistry System
- K202423 — MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)
- K202343 — MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )
- K201405 — LabPro Data Management System
- K201423 — MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)
- K193536 — MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)
- K193358 — MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)
- K192271 — Access PCT, Access PCT Calibrators
- K192355 — MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL)
- K190109 — MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)
- K183127 — MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL)
- K172787 — Access hsTnl
- K172783 — Access hs Tnl
- K172337 — MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL)
- K172912 — MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 8 µg/mL)
- K172255 — MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)
- K170524 — Access AMH
- K162740 — MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)
- K162208 — DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent
- K161837 — ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer
- K162414 — UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System
- K153651 — Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems
- K152346 — MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)
- K141932 — AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS
- K142985 — UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator
- K142373 — Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst
- K142362 — Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno.
- K140496 — Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents
- K140911 — UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM
- K140829 — UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT
- K131189 — UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)
- K130122 — BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER
- K130020 — ACCESS TOTAL BHCG (5TH IS)
- K121790 — ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
- K130373 — NAVIOS FLOW CYTOMETER SYSTEM
- K121445 — TETRACHROME REAGENTS AND TETRACXP SYSTEM
- K130253 — TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION
- K121214 — ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM
- K120771 — UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
- K120199 — GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY
- K121492 — UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT
- K112933 — ACCESS THYROGLOBULIN ANITBODY
- K112412 — AU5800(R) CHEMISTRY ANALYZER
- K112603 — ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS
- K111952 — ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033
- K110251 — SYNCHRON MULTI CALIBRATOR
- K110413 — POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS
- K103842 — UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0
- K103373 — SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722
- K100790 — COULTER LIN-X LINEARITY CONTROL, MODEL A81196
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