Medical Device Manufacturer · US , Walker , MI

Kabivitrum, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1981

8

Total

8

Cleared

0

Denied

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

7 devices

1-7 of 7

Cleared Dec 13, 1988

COATEST PROTEIN C

Hematology · 78d

Cleared Feb 26, 1986

COATEST PLASMINOGEN

Hematology · 104d

Cleared Jan 30, 1984

COATEST ANTIPLASMIN

Hematology · 82d

Cleared Jan 30, 1984

COATEST HEPARIN

Hematology · 82d

Cleared Jan 30, 1984

COATEST FACTOR VIII

Hematology · 82d

Cleared Aug 26, 1983

COATEST FACTOR X

Hematology · 57d

Cleared Dec 30, 1981

COATEST ANTITHROMBIN

Hematology · 83d