Medical Device Manufacturer · US , Chaska , MN

Beckman Coulter, Inc.

269 submissions · 269 cleared · Since 1993
269
Total
269
Cleared
0
Denied

Beckman Coulter, Inc. — FDA 510(k) Submissions

Beckman Coulter, Inc. has submitted 269 FDA 510(k) premarket notifications since 1993, of which 269 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Counter, Differential Cell, Panels, Test, Susceptibility, Antimicrobial, Mixture, Hematology Quality Control, Immunoassay Method, Troponin Subunit, Single (specified) Analyte Controls (assayed And Unassayed) . Use the specialty filter in the sidebar to narrow results.

269 devices
1–25 of 269
Access anti-HBc IgM
K254059 · SEI Qualitative And... · Microbiology
Mar 2026 86d
Access anti-HBc Total (C39432) Access anti-HBc Total Calibrator (C39433) Access anti-HBc Total QC (C39434)
K253687 · SEI Qualitative And... · Microbiology
Feb 2026 90d
Access anti-HAV IgM
K251995 · LOL Hepatitis A Test... · Microbiology
Jan 2026 214d
Access Rubella IgG
K250588 · LFX Enzyme Linked... · Microbiology
Nov 2025 263d
iQ200 Series
K252580 · LKM Counter, Urine Particle · Hematology
Sep 2025 26d
Access anti-HAV
K243846 · LOL Hepatitis A Test... · Microbiology
Sep 2025 267d
MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 ?g/mL) (MicroScan)
K243804 · LTT Panels, Test,... · Microbiology
Aug 2025 252d
MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 ?g/mL)
K250036 · LTT Panels, Test,... · Microbiology
Aug 2025 219d
Access hsTnI
K243483 · MMI Immunoassay Method,... · Chemistry
Aug 2025 266d
MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 ?g/mL)
K250084 · LTT Panels, Test,... · Microbiology
Jul 2025 186d
Access hsTnI
K242870 · MMI Immunoassay Method,... · Chemistry
Jun 2025 266d
Access Toxo IgG
K242022 · LGD Enzyme Linked... · Microbiology
Mar 2025 260d
Access Cortisol; DxC 500i Clinical Analyzer
K242190 · CGR Radioimmunoassay, Cortisol · Chemistry
Mar 2025 223d
Access Toxo IgM II
K242095 · LGD Enzyme Linked... · Microbiology
Oct 2024 86d
Access Syphilis
K241427 · LIP Enzyme Linked... · Microbiology
Sep 2024 109d
Access TPO Antibody
K240469 · JZO System, Test, Thyroid... · Immunology
Aug 2024 171d
UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System
K240252 · GKZ Counter, Differential Cell · Hematology
Jul 2024 157d
Access sTfR
K240987 · DDG Transferrin, Antigen,... · Immunology
Jul 2024 84d
Access Thyroglobulin Antibody II
K240996 · JNL Immunochemical,... · Immunology
Jul 2024 83d
Access Thyroglobulin
K240927 · MSW System, Test, Thyroglobulin · Immunology
Jun 2024 85d
Access Thyroglobulin
K241423 · MSW System, Test, Thyroglobulin · Immunology
Jun 2024 18d
Access OV Monitor
K240479 · LTK Test, Epithelial Ovarian... · Immunology
May 2024 80d
Access BR Monitor
K240403 · MOI System, Test,... · Immunology
May 2024 90d
Access Intrinsic Factor Ab
K240800 · LIG Radioassay, Intrinsic... · Chemistry
May 2024 39d
Access EPO
K240182 · GGT Assay, Erythropoietin · Hematology
Apr 2024 90d

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