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Beckman Coulter, Inc.

FDA 510(k) & PMA Approved Devices — 77 products

Total Devices77
Categories45
Latest FDA decision2026-03-24
TypeNumberDevice NameCodeDateActions
510(k) K252169 Access BNP IINBC2026-03-24 View
510(k) K254059 Access anti-HBc IgMSEI2026-03-13 View
510(k) K253687 Access anti-HBc TotalSEI2026-02-19 View
510(k) K251995 Access anti-HAV IgMLOL2026-01-27 View
510(k) K250588 Access Rubella IgGLFX2025-11-17 View
PMA P980041 KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTSLOK2025-11-03 View
PMA P230015 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2025-10-17 View
510(k) K252580 iQ200 SeriesLKM2025-09-10 View
510(k) K243846 Access anti-HAVLOL2025-09-09 View
510(k) K243804 MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)LTT2025-08-20 View
510(k) K250036 MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)LTT2025-08-15 View
510(k) K243483 Access hsTnIMMI2025-08-01 View
510(k) K250084 MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)LTT2025-07-18 View
510(k) K242870 Access hsTnIMMI2025-06-16 View
PMA P090026 P2psaOYA2025-06-16 View
PMA P970038 Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditionsMTG2025-05-15 View
510(k) K242022 Access Toxo IgGLGD2025-03-28 View
510(k) K242190 Access Cortisol; DxC 500i Clinical AnalyzerCGR2025-03-05 View
510(k) K242095 Access Toxo IgM IILGD2024-10-11 View
510(k) K241427 Access SyphilisLIP2024-09-06 View

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