Hoffmann-La Roche, Inc. - FDA 510(k) Cleared Devices
49
Total
49
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hoffmann-La Roche, Inc. Chemistry ✕
27 devices
Cleared
Jun 25, 1985
BHCG-ROCHE EIA
Chemistry
123d
Cleared
Jul 19, 1983
RENAK
Chemistry
56d
Cleared
Jan 07, 1983
COBAS STANDARDS FOR CREATININE
Chemistry
32d
Cleared
Jan 07, 1983
COBAS REAGENT FOR CREATININE
Chemistry
32d
Cleared
Jan 07, 1983
COBAS REAGENT FOR ALBUMIN
Chemistry
32d
Cleared
Jan 07, 1983
COBAS STANDARDS FOR ALBUMIN
Chemistry
32d
Cleared
Jan 07, 1983
COBAS STANDARD FOR TOTAL PROTEIN
Chemistry
32d
Cleared
Jan 07, 1983
COBAS REAGENT FOR CALCIUM
Chemistry
32d
Cleared
Jan 07, 1983
COBAS STANDARDS FOR CALCIUM-IN-ORGANIC
Chemistry
32d
Cleared
Jan 07, 1983
COBAS REAGENT FOR TOTAL PROTEIN
Chemistry
32d
Cleared
Jan 07, 1983
COBAS REAGENT FOR INORGANIC PHOSPHORUS
Chemistry
32d
Cleared
Nov 29, 1982
ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE
Chemistry
32d