Medical Device Manufacturer · US , Mchenry , IL

Diagnostic Specialties - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1981

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Diagnostic Specialties Hematology ✕

2 devices

1-2 of 2

Cleared Aug 30, 1994

ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT

Hematology · 182d

Cleared Aug 19, 1993

PROTEIN-BOUND GLUCOSE ASSAYN KIT

Hematology · 183d