Medical Device Manufacturer · US , Walker , MI

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

41 submissions · 41 cleared · Since 1981

41

Total

41

Cleared

0

Denied

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

5 devices

1-5 of 5

Cleared Dec 28, 1988

KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT

Hematology · 64d

Cleared Oct 31, 1988

KD 0.1 M SODIUM CITRATE SOLUTION

Hematology · 67d

Cleared Oct 31, 1988

KD 0.02 M CALCIUM CHLORIDE SOLUTION

Hematology · 67d

Cleared Oct 31, 1988

KD ONE-STAGE PROTHROMBIN TIME TEST

Hematology · 67d

Cleared Aug 25, 1981

KING DIAGNOSTICS HEMOGLOBIN TEST

Hematology · 29d