Medical Device Manufacturer · US , Miami , FL

Beckman Coulter - FDA 510(k) Cleared Devices

8 submissions · 6 cleared · Since 2017

Recent clearances: Access Ostase, Unicel DxH 800 Coulter Cellular Analysis System, Cytomics FC 500 Series (MPL or MCL) Flow Cytometer

Official Website

8

Total

6

Cleared

1

Denied

FDA 510(k) Regulatory Record - Beckman Coulter Immunology ✕

4 devices

1-4 of 4

Cleared Sep 06, 2019

Cytomics FC 500 Series (MPL or MCL) Flow Cytometer

Immunology · 326d

Cleared CT Mar 21, 2019

ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow...

Immunology · 90d

Not Cleared Jun 29, 2017

ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M

DEN160047 · PWD

Immunology · 269d

Cleared Jun 23, 2017

Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8...

Immunology · 249d