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. Immunology ✕

6 devices

1-6 of 6

Cleared Feb 26, 1986

CPR SLIDE EIKEN

Immunology · 85d

Cleared Jan 17, 1986

Immunology · 45d

Cleared Dec 17, 1981

FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN

Immunology · 125d

Cleared Apr 08, 1981

Immunology · 8d

Cleared Jan 05, 1981

RA 80 EIKEN KIT DETERM. OF RHEUMATIC F.

Immunology · 89d

Cleared Nov 12, 1980

GESTE FOLLOW KIT DETERM. OF HPL

Immunology · 35d