Medical Device Manufacturer · US , Chaska , MN

Beckman Coulter, Inc. - FDA 510(k) Cleared Devices

270 submissions · 270 cleared · Since 1993

Recent clearances: Access BNP II, Access anti-HBc IgM, Access anti-HBc Total

Official Website
270
Total
270
Cleared
0
Denied

FDA 510(k) Regulatory Record - Beckman Coulter, Inc. Chemistry ✕

117 devices
1-12 of 117
Cleared Mar 24, 2026
Access BNP II
K252169 · NBC
Chemistry · 257d
Cleared Aug 01, 2025
Access hsTnI
K243483 · MMI
Chemistry · 266d
Cleared Jun 16, 2025
Access hsTnI
K242870 · MMI
Chemistry · 266d
Cleared Mar 05, 2025
Access Cortisol
K242190 · CGR
Chemistry · 223d
Cleared May 03, 2024
Access Intrinsic Factor Ab
K240800 · LIG
Chemistry · 39d
Cleared Apr 12, 2024
Access NT-proBNP
K232164 · NBC
Chemistry · 266d
Cleared Mar 06, 2024
Access Free T4
K240273 · CEC
Chemistry · 35d
Cleared Mar 01, 2024
Access Intact PTH
K232791 · CEW
Chemistry · 172d
Cleared Feb 16, 2024
Access CK-MB
K234005 · JHX
Chemistry · 59d
Cleared Feb 08, 2024
Access SHBG
K233480 · CDZ
Chemistry · 105d
Cleared Dec 18, 2023
Access hsTnI
K222881 · MMI
Chemistry · 452d
Cleared Dec 04, 2023
Access hsTnI
K230648 · MMI
Chemistry · 270d

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