Medical Device Manufacturer · US , Walker , MI

Syn-Kit, Inc. - FDA 510(k) Cleared Devices

34 submissions · 34 cleared · Since 1980

34

Total

34

Cleared

0

Denied

FDA 510(k) Regulatory Record - Syn-Kit, Inc. Chemistry ✕

17 devices

1-12 of 17

Cleared Dec 18, 1984

UROPAPER EIKEN GP

Chemistry · 84d

Cleared Dec 18, 1984

UROPAPER EIKEN 7

Chemistry · 84d

Cleared Dec 18, 1984

UROPAPER EIKEN 6B

Chemistry · 84d

Cleared Dec 18, 1984

UROPAPER EIKEN 5

Chemistry · 84d

Cleared Dec 18, 1984

UROPAPER EIKEN AG

Chemistry · 84d

Cleared Dec 18, 1984

UROPAPER EIKEN GK

Chemistry · 84d

Cleared Dec 18, 1984

UROPAPER EIKEN HAG

Chemistry · 84d

Cleared Dec 18, 1984

UROPAPER EIKEN G

Chemistry · 84d

Cleared Dec 12, 1984

UROPAPER EIKEN 8

Chemistry · 96d

Cleared Jan 11, 1984

REAGENT TESTS STRIP COMBINATIONS

Chemistry · 92d

Cleared May 14, 1982

URICASE (U.V.) URIC ACID

Chemistry · 17d

Cleared May 05, 1982

CHOLESTEZYME-V EIKEN

Chemistry · 15d