Medical Device Manufacturer · US , Mchenry , IL

Gamma Biologicals, Inc. - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 1976

21

Total

21

Cleared

0

Denied

FDA 510(k) Regulatory Record - Gamma Biologicals, Inc. Microbiology ✕

6 devices

1-6 of 6

Cleared Apr 16, 1980

RST-SERIES CONTROL

Microbiology · 21d

Cleared Aug 11, 1976

TEST, STREP, LATEX SLIDE

Microbiology · 58d

Cleared Aug 03, 1976

TEST, ANTIBODIES FOR GRP A, LATEX SLIDE

Microbiology · 50d

Cleared Aug 03, 1976

REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O

Microbiology · 50d

Cleared Aug 03, 1976

FEBRILE ANTIGENS & CONTROL SERUMS

Microbiology · 50d

Cleared Aug 03, 1976

Microbiology · 50d