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Gamma Enterprises, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
23
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K790578GAMMA SMAC REAGENTSMay 15, 1979
K780505SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASEMay 3, 1978
K780507SERUM GLUTAMIC-PYRUVIC TRANSAMINASEMay 3, 1978
K780506CARBON DIOXIDE REAGENTSMay 3, 1978
K780504CREATINE PHOSPHOKINASE (CPK)May 3, 1978
K771843WETTING AGENTSNovember 22, 1977
K771832CHLORIDENovember 22, 1977
K771836LACTATE DEHYDROGENASENovember 22, 1977
K771838SERUM IRONNovember 3, 1977
K771834CREATININENovember 3, 1977
K771839SODIUMNovember 2, 1977
K771829ALKALINE PHOSPHATASENovember 2, 1977
K771835INORGANIC PHOSPHORUSNovember 2, 1977
K771837POTASSIUMNovember 2, 1977
K771828ALBUMINOctober 25, 1977
K771844WASH SOLUTIONSOctober 25, 1977
K771831CALCIUMOctober 25, 1977
K771830BLOOD UREA NITROGEN BUNOctober 25, 1977
K771842URIC ACIDOctober 25, 1977
K771841TOTAL PROTEINOctober 25, 1977