Medical Device Manufacturer · US , Waukesha , WI

Immucor Gti Diagnostics, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2020

Recent clearances: PF4 Enhanced assay, PF4 IgG assay

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Immucor Gti Diagnostics, Inc. Hematology ✕

2 devices

1-2 of 2

Cleared Sep 11, 2020

PF4 Enhanced assay

Hematology · 92d

Cleared Jun 18, 2020

Hematology · 31d