Medical Device Manufacturer · US , San Luis Obispo , CA

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

22 submissions · 22 cleared · Since 1986

22

Total

22

Cleared

0

Denied

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

7 devices

1-7 of 7

Cleared Apr 20, 1987

PROTHROMBIN TIME TEST

Hematology · 69d

Cleared Apr 20, 1987

COAGULATION CONTROL, LEVEL I

Hematology · 60d

Cleared Apr 20, 1987

COAGULATION CONTROL, LEVEL II

Hematology · 60d

Cleared Apr 20, 1987

COAGULATION CONTROL, LEVEL III

Hematology · 60d

Cleared Apr 15, 1987

CYANMETHEMOGLOBIN STANDARD

Hematology · 15d

Cleared Mar 31, 1987

O.O2 M CALCIUM CHLORIDE SOLUTION

Hematology · 40d

Cleared Aug 21, 1986

U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK)

Hematology · 41d