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Gamma Biologicals, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
21
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K864207DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONODecember 3, 1986
K861016GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSISApril 18, 1986
K832473GAMMA SLIDE TEST FOR PREGNANCYAugust 16, 1983
K820647GAMMA FETAL BLEED SCREENING TESTMay 12, 1982
K820072FE-CULT PLUSMarch 4, 1982
K813342GAMMA CHLOROQUINE DIPHOSPHATE SOLUTIONMarch 4, 1982
K811752FE-CULT PLUSNovember 2, 1981
K802533GAMMA LEWIS BLOOD GROUP SUBSTANCENovember 12, 1980
K802534GAMMA PI BLOOD GROUP SUBSTANCENovember 12, 1980
K800658RST-SERIES CONTROLApril 16, 1980
K792582POLY-LEC SYSTEMJanuary 16, 1980
K792583GAMMA ARACHIS HYPOGEA LECTINJanuary 16, 1980
K790973LO-IONJune 15, 1979
K760034TEST, STREP, LATEX SLIDEAugust 11, 1976
K760032TEST, MONO., DIFFERENTIAL SLIDEAugust 3, 1976
K760036TEST, LATEX SLIDE, RHEUMATOID FACTORAugust 3, 1976
K760033TEST, ANTIBODIES FOR GRP A, LATEX SLIDEAugust 3, 1976
K760097FEBRILE ANTIGENS & CONTROL SERUMSAugust 3, 1976
K760035TEST, C-REATIVE PROTEIN, LATEX SLIDEAugust 3, 1976
K760096REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN OAugust 3, 1976