General Diagnostics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
39
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K882663BARBITURATE ENZYME IMMUNOASSAY KITSeptember 19, 1988
K872882CANNABINOID ENZYME IMMUNOASSAY KITNovember 3, 1987
K871305COCAINE METABOLITE ENZYME IMMUNOASSAY KITJune 5, 1987
K864993QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINEMarch 31, 1987
K863877BENZODIAZEPINE ENZYME IMMUNOASSAY KITMarch 12, 1987
K842307GENERAL DIAG. CEFONICID 30MCG ANTIMICJuly 20, 1984
K841465GENERAL DIAGNOSTICS PLATELET ANTIBODYJuly 2, 1984
K833709CEFTIZOXIME 30 MCG ANTIMICROBIAL DISKDecember 30, 1983
K832653CEFUROXIME 30MCG. SUSCEP DISKOctober 14, 1983
K831179CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEPMay 9, 1983
K830731NETILMICIN 30 MCG ANTIMICROBIAL DISKApril 8, 1983
K823453VON WILLEBRAND FACTOR ASSAYJanuary 21, 1983
K823794CONTROL TM 8January 14, 1983
K822809AZLOCILLIN 75 MCG SUSCEPTIBILITY DISCNovember 22, 1982
K821229CEFOPERAZONE 75MCG. ANTIMICROBIAL DISKJune 22, 1982
K820468PROFILE GENERAL SET ASSAYED SERUM CONTRMarch 25, 1982
K820019PIPERACILLIN 100MCG. ANTIMICROBIALJanuary 29, 1982
K813564COAG-A-MATE X2January 28, 1982
K812994MINOCYCLINE 30MCG ANTIMICROBIAL SUS. DSKDecember 17, 1981
K812993MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISKNovember 10, 1981