Medical Device Manufacturer · US , Chaska , MN

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

270 submissions · 270 cleared · Since 1993

270

Total

270

Cleared

Denied

Beckman Coulter, Inc. is a diagnostic device manufacturer headquartered in Chaska, US. The company specializes in clinical laboratory and immunodiagnostic systems.

Beckman Coulter has received 270 FDA 510(k) clearances from 270 total submissions since its first clearance in 1993. The company maintains active regulatory status, with the latest clearance in 2026. Its portfolio spans chemistry devices, microbiology testing systems, hematology analyzers, and immunoassay platforms.

Recent cleared devices include chemistry assays for cardiac markers, microbiology susceptibility panels, hematology analyzers, and serology testing systems. The company's product range addresses antimicrobial resistance detection, cardiovascular disease diagnostics, and infectious disease monitoring.

Explore the complete list of device names, product codes, and individual clearance dates in the database.

3 submissions have an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.

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

270 devices

1-12 of 270