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Hoffmann-La Roche, Inc.

FDA 510(k) & PMA Approved Devices — 49 products

Total Devices49
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K850727 BHCG-ROCHE EIAJHI1985-06-25 View
510(k) K831694 RENAKCIB1983-07-19 View
510(k) K830461 ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONEKXS1983-03-24 View
510(k) K830481 ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINELCL1983-03-24 View
510(k) K830482 ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINEDJP1983-03-24 View
510(k) K830462 ABUSCREEN RADIOUMMUNOASSAY--URINEDOE1983-03-24 View
510(k) K830480 ABUSCREEN RADIOIMMUNOASSAY-COCAINE METAKLN1983-03-24 View
510(k) K830460 ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINEDOE1983-03-24 View
510(k) K830479 ABUSCREEN RADIOIMMUNOASSAY-BARBITURATEDKN1983-03-10 View
510(k) K823574 COBAS REAGENT FOR ALBUMINCIX1983-01-07 View
510(k) K823580 COBAS REAGENT FOR INORGANIC PHOSPHORUSCEO1983-01-07 View
510(k) K823577 COBAS REAGENT FOR CALCIUMCIC1983-01-07 View
510(k) K823578 COBAS STANDARDS FOR CALCIUM-IN-ORGANICCIO1983-01-07 View
510(k) K823576 COBAS STANDARD FOR TOTAL PROTEINLER1983-01-07 View
510(k) K823573 COBAS REAGENT FOR CREATININECGX1983-01-07 View
510(k) K823579 COBAS REAGENT FOR TOTAL PROTEINCEK1983-01-07 View
510(k) K823575 COBAS STANDARDS FOR ALBUMINCIX1983-01-07 View
510(k) K823572 COBAS STANDARDS FOR CREATININECGX1983-01-07 View
510(k) K822219 HUMAN PLASMA CONTROL FOR CEA-ROCHEJJX1982-12-28 View
510(k) K823212 ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINEDJP1982-11-29 View
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