Medical Device Manufacturer · US , Mchenry , IL

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

21 submissions · 21 cleared · Since 1976

Recent clearances: DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO, GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS, GAMMA SLIDE TEST FOR PREGNANCY

21

Total

21

Cleared

0

Denied

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

5 devices

1-5 of 5

Cleared Dec 03, 1986

DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO

Immunology · 37d

Cleared Apr 18, 1986

GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS

Immunology · 31d

Cleared Aug 03, 1976

TEST, MONO., DIFFERENTIAL SLIDE

Immunology · 50d

Cleared Aug 03, 1976

TEST, C-REATIVE PROTEIN, LATEX SLIDE

Immunology · 50d

Cleared Aug 03, 1976

TEST, LATEX SLIDE, RHEUMATOID FACTOR

Immunology · 50d