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Beckman Coulter, Inc.

270 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Access BNP II (K252169)Beckman Coulter, Inc.2026-03-24
Access anti-HBc IgM (K254059)Beckman Coulter, Inc.2026-03-13
Access anti-HBc Total (K253687)Beckman Coulter, Inc.2026-02-19
Access anti-HAV IgM (K251995)Beckman Coulter, Inc.2026-01-27
Access Rubella IgG (K250588)Beckman Coulter, Inc.2025-11-17
iQ200 Series (K252580)Beckman Coulter, Inc.2025-09-10
Access anti-HAV (K243846)Beckman Coulter, Inc.2025-09-09
MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan) (K243804)Beckman Coulter, Inc.2025-08-20
MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) (K250036)Beckman Coulter, Inc.2025-08-15
Access hsTnI (K243483)Beckman Coulter, Inc.2025-08-01
MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) (K250084)Beckman Coulter, Inc.2025-07-18
Access hsTnI (K242870)Beckman Coulter, Inc.2025-06-16
Access Toxo IgG (K242022)Beckman Coulter, Inc.2025-03-28
Access Cortisol; DxC 500i Clinical Analyzer (K242190)Beckman Coulter, Inc.2025-03-05
Access Toxo IgM II (K242095)Beckman Coulter, Inc.2024-10-11
Access Syphilis (K241427)Beckman Coulter, Inc.2024-09-06
Access TPO Antibody (K240469)Beckman Coulter, Inc.2024-08-09
UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System (K240252)Beckman Coulter, Inc.2024-07-05
Access Thyroglobulin Antibody II (K240996)Beckman Coulter, Inc.2024-07-03
Access sTfR (K240987)Beckman Coulter, Inc.2024-07-03
Access Thyroglobulin (K240927)Beckman Coulter, Inc.2024-06-28
Access Thyroglobulin (K241423)Beckman Coulter, Inc.2024-06-07
Access OV Monitor (K240479)Beckman Coulter, Inc.2024-05-10
Access BR Monitor (K240403)Beckman Coulter, Inc.2024-05-09
Access Intrinsic Factor Ab (K240800)Beckman Coulter, Inc.2024-05-03
Access EPO (K240182)Beckman Coulter, Inc.2024-04-22
Access NT-proBNP (K232164)Beckman Coulter, Inc.2024-04-12
Access Ferritin (K234052)Beckman Coulter, Inc.2024-03-20
Access Free T4 (K240273)Beckman Coulter, Inc.2024-03-06
Access Intact PTH (K232791)Beckman Coulter, Inc.2024-03-01
Access CK-MB (K234005)Beckman Coulter, Inc.2024-02-16
Access SHBG (K233480)Beckman Coulter, Inc.2024-02-08
Access hsTnI (K222881)Beckman Coulter, Inc.2023-12-18
Access hsTnI (K230648)Beckman Coulter, Inc.2023-12-04
DxFLEX Flow Cytometer; ClearLLab 10C Panels (K232600)Beckman Coulter, Inc.2023-11-22
Access Thyroglobulin Antibody II (K213517)Beckman Coulter, Inc.2023-09-26
Access CEA (K223921)Beckman Coulter, Inc.2023-09-22
Access Myoglobin (K231832)Beckman Coulter, Inc.2023-09-18
Access Thyroglobulin (K220972)Beckman Coulter, Inc.2023-09-15
Access Folate Assay (K223590)Beckman Coulter, Inc.2023-08-23
Access PCT (K222996)Beckman Coulter, Inc.2023-04-26
MicroScan Prompt Inoculation System-D (K221493)Beckman Coulter, Inc.2023-04-05
Access Cortisol (K223038)Beckman Coulter, Inc.2023-02-08
Access AMH (K223679)Beckman Coulter, Inc.2023-02-03
Access 25(OH) Vitamin D Total (K223503)Beckman Coulter, Inc.2023-01-19
Access Testosterone (K223405)Beckman Coulter, Inc.2023-01-13
Access Total ßhCG (5th IS) (K221990)Beckman Coulter, Inc.2022-12-27
Access Vitamin B12 (K223289)Beckman Coulter, Inc.2022-12-23
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer (K221225)Beckman Coulter, Inc.2022-11-10
Total Immunoglobulin E (IgE) (K220178)Beckman Coulter, Inc.2022-03-23
iQ200 System, iChemVELOCITY Automated Urine Chemistry System (K210127)Beckman Coulter, Inc.2021-07-02
MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL) (K202423)Beckman Coulter, Inc.2021-05-18
MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL ) (K202343)Beckman Coulter, Inc.2020-11-16
LabPro Data Management System (K201405)Beckman Coulter, Inc.2020-08-30
MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL) (K201423)Beckman Coulter, Inc.2020-06-29
MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL) (K193536)Beckman Coulter, Inc.2020-03-18
MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL) (K193358)Beckman Coulter, Inc.2020-03-03
Access PCT, Access PCT Calibrators (K192271)Beckman Coulter, Inc.2019-11-26
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL) (K192355)Beckman Coulter, Inc.2019-11-14
MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) (K190109)Beckman Coulter, Inc.2019-04-18
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL) (K183127)Beckman Coulter, Inc.2019-02-12
Access hsTnl (K172787)Beckman Coulter, Inc.2018-06-14
Access hs Tnl (K172783)Beckman Coulter, Inc.2018-06-12
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL) (K172337)Beckman Coulter, Inc.2017-12-15
MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL) (K172912)Beckman Coulter, Inc.2017-12-07
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) (K172255)Beckman Coulter, Inc.2017-12-01
Access AMH (K170524)Beckman Coulter, Inc.2017-11-13
MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL) (K162740)Beckman Coulter, Inc.2017-03-21
DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent (K162208)Beckman Coulter, Inc.2017-01-09
ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer (K161837)Beckman Coulter, Inc.2016-12-16
UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System (K162414)Beckman Coulter, Inc.2016-11-29
Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems (K153651)Beckman Coulter, Inc.2016-08-18
MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL) (K152346)Beckman Coulter, Inc.2015-09-16
AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS (K141932)Beckman Coulter, Inc.2015-04-10
UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator (K142985)Beckman Coulter, Inc.2015-02-26
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 (K142373)Beckman Coulter, Inc.2014-12-22
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. (K142362)Beckman Coulter, Inc.2014-12-19
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 (K140496)Beckman Coulter, Inc.2014-09-16
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM (K140911)Beckman Coulter, Inc.2014-09-05
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT (K140829)Beckman Coulter, Inc.2014-07-14
UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH) (K131189)Beckman Coulter, Inc.2014-04-17
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER (K130122)Beckman Coulter, Inc.2014-01-07
ACCESS TOTAL BHCG (5TH IS) (K130020)Beckman Coulter, Inc.2013-10-01
ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (K121790)Beckman Coulter, Inc.2013-09-25
NAVIOS FLOW CYTOMETER SYSTEM (K130373)Beckman Coulter, Inc.2013-09-18
TETRACHROME REAGENTS AND TETRACXP SYSTEM (K121445)Beckman Coulter, Inc.2013-07-26
TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION (K130253)Beckman Coulter, Inc.2013-07-15
ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM (K121214)Beckman Coulter, Inc.2013-06-14
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM (K120771)Beckman Coulter, Inc.2013-03-22
GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY (K120199)Beckman Coulter, Inc.2012-10-12
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT (K121492)Beckman Coulter, Inc.2012-09-11
ACCESS THYROGLOBULIN ANITBODY (K112933)Beckman Coulter, Inc.2011-12-27
AU5800(R) CHEMISTRY ANALYZER (K112412)Beckman Coulter, Inc.2011-12-23
ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS (K112603)Beckman Coulter, Inc.2011-11-04
ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033 (K111952)Beckman Coulter, Inc.2011-08-19
SYNCHRON MULTI CALIBRATOR (K110251)Beckman Coulter, Inc.2011-05-25
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS (K110413)Beckman Coulter, Inc.2011-05-11
UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 (K103842)Beckman Coulter, Inc.2011-04-27
SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 (K103373)Beckman Coulter, Inc.2011-02-07
COULTER LIN-X LINEARITY CONTROL, MODEL A81196 (K100790)Beckman Coulter, Inc.2010-12-21
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