Medical Device Manufacturer · US , Walker , MI

Em Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices

288 submissions · 288 cleared · Since 1984

288

Total

288

Cleared

0

Denied

FDA 510(k) Regulatory Record - Em Diagnostic Systems, Inc. Hematology ✕

4 devices

1-4 of 4

Cleared Dec 03, 1992

Hematology · 76d

Cleared Jan 27, 1989

EASY-TEST PARTIAL THROMBOPLASTIN TIME PTT #16629

Hematology · 79d

Cleared Feb 11, 1988

EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628

Hematology · 64d

Cleared Jul 23, 1987

EASY-TEST HEMOGLOBIN (HGB) ITEM #16685

Hematology · 16d