Medical Device Manufacturer · US , Walker , MI

Cardiovascular Diagnostic Services - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1981

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cardiovascular Diagnostic Services Hematology ✕

7 devices

1-7 of 7

Cleared Mar 18, 1996

Hematology · 83d

Cleared Nov 15, 1993

Hematology · 144d

Cleared Jan 25, 1991

COAG-1 PT-NC TEST CARD

Hematology · 127d

Cleared Aug 01, 1990

MODIFIED COAG-1 PT TEST CARD

Hematology · 21d

Cleared May 22, 1989

COAG-1 APTT TEST CARD

Hematology · 83d

Cleared Aug 25, 1988

COAG-I ANALYZER, ALPHA MODEL

Hematology · 72d

Cleared Aug 25, 1988

COAG-I PT TEST CARD

Hematology · 72d