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Hoffmann-La Roche, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
49
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K850727BHCG-ROCHE EIAJune 25, 1985
K831694RENAKJuly 19, 1983
K830480ABUSCREEN RADIOIMMUNOASSAY-COCAINE METAMarch 24, 1983
K830481ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINEMarch 24, 1983
K830462ABUSCREEN RADIOUMMUNOASSAY--URINEMarch 24, 1983
K830460ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINEMarch 24, 1983
K830482ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINEMarch 24, 1983
K830461ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONEMarch 24, 1983
K830479ABUSCREEN RADIOIMMUNOASSAY-BARBITURATEMarch 10, 1983
K823573COBAS REAGENT FOR CREATININEJanuary 7, 1983
K823578COBAS STANDARDS FOR CALCIUM-IN-ORGANICJanuary 7, 1983
K823572COBAS STANDARDS FOR CREATININEJanuary 7, 1983
K823576COBAS STANDARD FOR TOTAL PROTEINJanuary 7, 1983
K823580COBAS REAGENT FOR INORGANIC PHOSPHORUSJanuary 7, 1983
K823575COBAS STANDARDS FOR ALBUMINJanuary 7, 1983
K823577COBAS REAGENT FOR CALCIUMJanuary 7, 1983
K823574COBAS REAGENT FOR ALBUMINJanuary 7, 1983
K823579COBAS REAGENT FOR TOTAL PROTEINJanuary 7, 1983
K822219HUMAN PLASMA CONTROL FOR CEA-ROCHEDecember 28, 1982
K823212ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINENovember 29, 1982