Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Beckman Coulter, Inc.

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

Total Devices77
Categories45
Latest Approval2026-03-24
TypeNumberDevice NameCodeDate
510(k) K252169 Access BNP II NBC 2026-03-24 View
510(k) K254059 Access anti-HBc IgM SEI 2026-03-13 View
510(k) K253687 Access anti-HBc Total SEI 2026-02-19 View
510(k) K251995 Access anti-HAV IgM LOL 2026-01-27 View
510(k) K250588 Access Rubella IgG LFX 2025-11-17 View
PMA P230015 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) LOM 2025-10-17 View
510(k) K252580 iQ200 Series LKM 2025-09-10 View
510(k) K243846 Access anti-HAV LOL 2025-09-09 View
510(k) K243804 MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan) LTT 2025-08-20 View
510(k) K250036 MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) LTT 2025-08-15 View
510(k) K243483 Access hsTnI MMI 2025-08-01 View
510(k) K250084 MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) LTT 2025-07-18 View
510(k) K242870 Access hsTnI MMI 2025-06-16 View
510(k) K242022 Access Toxo IgG LGD 2025-03-28 View
510(k) K242190 Access Cortisol; DxC 500i Clinical Analyzer CGR 2025-03-05 View
510(k) K242095 Access Toxo IgM II LGD 2024-10-11 View
510(k) K241427 Access Syphilis LIP 2024-09-06 View
510(k) K240469 Access TPO Antibody JZO 2024-08-09 View
510(k) K240252 UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System GKZ 2024-07-05 View
510(k) K240987 Access sTfR DDG 2024-07-03 View
510(k) K240996 Access Thyroglobulin Antibody II JNL 2024-07-03 View
510(k) K240927 Access Thyroglobulin MSW 2024-06-28 View
510(k) K241423 Access Thyroglobulin MSW 2024-06-07 View
510(k) K240479 Access OV Monitor LTK 2024-05-10 View
510(k) K240403 Access BR Monitor MOI 2024-05-09 View
510(k) K240800 Access Intrinsic Factor Ab LIG 2024-05-03 View
510(k) K240182 Access EPO GGT 2024-04-22 View
510(k) K232164 Access NT-proBNP NBC 2024-04-12 View
510(k) K234052 Access Ferritin JMG 2024-03-20 View
510(k) K240273 Access Free T4 CEC 2024-03-06 View
510(k) K232791 Access Intact PTH CEW 2024-03-01 View
510(k) K234005 Access CK-MB JHX 2024-02-16 View
510(k) K233480 Access SHBG CDZ 2024-02-08 View
510(k) K222881 Access hsTnI MMI 2023-12-18 View
510(k) K230648 Access hsTnI MMI 2023-12-04 View
510(k) K232600 DxFLEX Flow Cytometer; ClearLLab 10C Panels OYE 2023-11-22 View
510(k) K213517 Access Thyroglobulin Antibody II JZO 2023-09-26 View
510(k) K223921 Access CEA DHX 2023-09-22 View
510(k) K231832 Access Myoglobin DDR 2023-09-18 View
510(k) K220972 Access Thyroglobulin MSW 2023-09-15 View
510(k) K223590 Access Folate Assay CGN 2023-08-23 View
510(k) K222996 Access PCT PTF 2023-04-26 View
510(k) K221493 MicroScan Prompt Inoculation System-D LIE 2023-04-05 View
510(k) K223038 Access Cortisol CGR 2023-02-08 View
510(k) K223679 Access AMH PQO 2023-02-03 View
510(k) K223503 Access 25(OH) Vitamin D Total MRG 2023-01-19 View
510(k) K223405 Access Testosterone CDZ 2023-01-13 View
510(k) K221990 Access Total ßhCG (5th IS) DHA 2022-12-27 View
510(k) K223289 Access Vitamin B12 CDD 2022-12-23 View
510(k) K221225 Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer JLW 2022-11-10 View
510(k) K220178 Total Immunoglobulin E (IgE) DGC 2022-03-23 View
510(k) K210127 iQ200 System, iChemVELOCITY Automated Urine Chemistry System LKM 2021-07-02 View
510(k) K202423 MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL) JWY 2021-05-18 View
510(k) K202343 MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL ) LTT 2020-11-16 View
510(k) K201405 LabPro Data Management System LON 2020-08-30 View
510(k) K201423 MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL) LTT 2020-06-29 View
510(k) K193536 MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL) LTT 2020-03-18 View
510(k) K193358 MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL) LTT 2020-03-03 View
510(k) K192271 Access PCT, Access PCT Calibrators PTF 2019-11-26 View
510(k) K192355 MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL) JWY 2019-11-14 View
510(k) K190109 MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) JWY 2019-04-18 View
510(k) K183127 MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL) LTT 2019-02-12 View
510(k) K172787 Access hsTnl MMI 2018-06-14 View
510(k) K172783 Access hs Tnl MMI 2018-06-12 View
510(k) K172337 MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL) LTT 2017-12-15 View
510(k) K172912 MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL) LTT 2017-12-07 View
510(k) K172255 MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) LTT 2017-12-01 View
510(k) K170524 Access AMH PQO 2017-11-13 View
PMA P970038 Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions MTG 2017-10-24 View
PMA P090026 P2psa OYA 2017-10-24 View
510(k) K162740 MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL) LTT 2017-03-21 View
510(k) K162208 DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent CFN 2017-01-09 View
510(k) K161837 ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer JGS 2016-12-16 View
510(k) K162414 UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System GKZ 2016-11-29 View
PMA P980041 KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS LOK 2016-11-18 View
PMA P850048 Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer MTF 2016-11-09 View
510(k) K153651 Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems JLW 2016-08-18 View
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