Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

269 results for "Beckman Coulter, Inc."
1–24 of 269
Cleared Mar 13, 2026
Access anti-HBc IgM
K254059 · SEI
Beckman Coulter, Inc.
Microbiology · 86d
Cleared Feb 19, 2026
Access anti-HBc Total
K253687 · SEI
Beckman Coulter, Inc.
Microbiology · 90d
Cleared Jan 27, 2026
Access anti-HAV IgM
K251995 · LOL
Beckman Coulter, Inc.
Microbiology · 214d
Cleared Nov 17, 2025
Access Rubella IgG
K250588 · LFX
Beckman Coulter, Inc.
Microbiology · 263d
Cleared Sep 10, 2025
iQ200 Series
K252580 · LKM
Beckman Coulter, Inc.
Hematology · 26d
Cleared Sep 09, 2025
Access anti-HAV
K243846 · LOL
Beckman Coulter, Inc.
Microbiology · 267d
Cleared Aug 20, 2025
MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64...
K243804 · LTT
Beckman Coulter, Inc.
Microbiology · 252d
Cleared Aug 15, 2025
MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32...
K250036 · LTT
Beckman Coulter, Inc.
Microbiology · 219d
Cleared Aug 01, 2025
Access hsTnI
K243483 · MMI
Beckman Coulter, Inc.
Chemistry · 266d
Cleared Jul 18, 2025
MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64...
K250084 · LTT
Beckman Coulter, Inc.
Microbiology · 186d
Cleared Jun 16, 2025
Access hsTnI
K242870 · MMI
Beckman Coulter, Inc.
Chemistry · 266d
Cleared Mar 28, 2025
Access Toxo IgG
K242022 · LGD
Beckman Coulter, Inc.
Microbiology · 260d
Cleared Mar 05, 2025
Access Cortisol
K242190 · CGR
Beckman Coulter, Inc.
Chemistry · 223d
Cleared Oct 11, 2024
Access Toxo IgM II
K242095 · LGD
Beckman Coulter, Inc.
Microbiology · 86d
Cleared Sep 06, 2024
Access Syphilis
K241427 · LIP
Beckman Coulter, Inc.
Microbiology · 109d
Cleared Aug 09, 2024
Access TPO Antibody
K240469 · JZO
Beckman Coulter, Inc.
Immunology · 171d
Cleared Jul 05, 2024
UniCel DxH 900 Coulter Cellular Analysis System
K240252 · GKZ
Beckman Coulter, Inc.
Hematology · 157d
Cleared Jul 03, 2024
Access Thyroglobulin Antibody II
K240996 · JNL
Beckman Coulter, Inc.
Immunology · 83d
Cleared Jul 03, 2024
Access sTfR
K240987 · DDG
Beckman Coulter, Inc.
Immunology · 84d
Cleared Jun 28, 2024
Access Thyroglobulin
K240927 · MSW
Beckman Coulter, Inc.
Immunology · 85d
Cleared Jun 07, 2024
Access Thyroglobulin
K241423 · MSW
Beckman Coulter, Inc.
Immunology · 18d
Cleared May 10, 2024
Access OV Monitor
K240479 · LTK
Beckman Coulter, Inc.
Immunology · 80d
Cleared May 09, 2024
Access BR Monitor
K240403 · MOI
Beckman Coulter, Inc.
Immunology · 90d
Cleared May 03, 2024
Access Intrinsic Factor Ab
K240800 · LIG
Beckman Coulter, Inc.
Chemistry · 39d