Medical Device Manufacturer · US , Mchenry , IL

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

21 submissions · 21 cleared · Since 1976

Total

Cleared

Denied

Gamma Biologicals, Inc. has 21 FDA 510(k) cleared medical devices. Based in Mchenry, US.

Historical record: 21 cleared submissions from 1976 to 1986.

Browse the FDA 510(k) cleared devices submitted by Gamma Biologicals, Inc. Filter by specialty or product code using the sidebar.

Gamma Biologicals, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

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

21 devices

1-21 of 21

Cleared Dec 03, 1986

DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO

K864207 · KTN

Immunology · 37d

Cleared Apr 18, 1986

GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS

K861016 · KTN

Immunology · 31d

Cleared Aug 16, 1983

GAMMA SLIDE TEST FOR PREGNANCY

K832473 · JHJ

Chemistry · 21d

Cleared May 12, 1982

GAMMA FETAL BLEED SCREENING TEST

K820647 · LIM

Hematology · 64d

Cleared Mar 04, 1982

GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION

GAMMA LEWIS BLOOD GROUP SUBSTANCE

K802533 · KSX

Hematology · 28d

Cleared Nov 12, 1980

GAMMA PI BLOOD GROUP SUBSTANCE

GAMMA ARACHIS HYPOGEA LECTIN

TEST, STREP, LATEX SLIDE

K760034 · DEM

Microbiology · 58d

Cleared Aug 03, 1976

TEST, MONO., DIFFERENTIAL SLIDE

K760032 · KIN

Immunology · 50d

Cleared Aug 03, 1976

TEST, ANTIBODIES FOR GRP A, LATEX SLIDE

K760033 · GTZ

Microbiology · 50d

Cleared Aug 03, 1976

TEST, C-REATIVE PROTEIN, LATEX SLIDE

K760035 · DCK

Immunology · 50d

Cleared Aug 03, 1976

TEST, LATEX SLIDE, RHEUMATOID FACTOR

K760036 · DHR

Immunology · 50d

Cleared Aug 03, 1976

REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O

K760096 · GTQ

Microbiology · 50d

Cleared Aug 03, 1976

FEBRILE ANTIGENS & CONTROL SERUMS

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

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

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