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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
K802534GAMMA PI BLOOD GROUP SUBSTANCENovember 12, 1980
K802533GAMMA LEWIS 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
K760098REAGENT, VDRLAugust 3, 1976
K760035TEST, C-REATIVE PROTEIN, LATEX SLIDEAugust 3, 1976
K760032TEST, MONO., DIFFERENTIAL SLIDEAugust 3, 1976
K760096REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN OAugust 3, 1976
K760033TEST, ANTIBODIES FOR GRP A, LATEX SLIDEAugust 3, 1976
K760097FEBRILE ANTIGENS & CONTROL SERUMSAugust 3, 1976