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. Microbiology ✕

10 devices

1-10 of 10

Cleared Aug 12, 1986

SEROIDEN STREPTO KIT 'EIKEN'

Microbiology · 141d

Cleared Jun 10, 1986

SLIDE CULTURE U 'EIKEN'

Microbiology · 42d

Cleared Aug 20, 1985

ASO SLIDE EIKEN

Microbiology · 15d

Cleared Jun 12, 1983

URINE SCREENING KIT

Microbiology · 89d

Cleared Apr 14, 1982

TREP CARD EIKEN

Microbiology · 43d

Cleared Dec 31, 1981

SYSTEK #1 EIKEN

Microbiology · 51d

Cleared Dec 08, 1981

UROPAPER EIKEN UHAG

Microbiology · 165d

Cleared Jul 23, 1981

UROPAPER EIKEN UAG

Microbiology · 27d

Cleared Jul 15, 1981

UROPAPER EIKEN AG

Microbiology · 19d

Cleared Dec 18, 1980

TOXOTEST-MT EIKEN KIT

Microbiology · 71d