Medical Device Manufacturer · US , Hialeah , FL

Coulter Immunology - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 1988

Recent clearances: CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1, CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1, CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC

View 16 510(k) Devices ↓

16

Total

16

Cleared

0

Denied

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

1 devices

1-1 of 1

Cleared Aug 03, 1989

COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM)

Microbiology · 93d