Medical Device Manufacturer · US , Mchenry , IL

Hoffmann-La Roche, Inc.

49 submissions · 49 cleared · Since 1976
49
Total
49
Cleared
0
Denied

Hoffmann-La Roche, Inc. — FDA 510(k) Submissions

Hoffmann-La Roche, Inc. has submitted 49 FDA 510(k) premarket notifications since 1976, of which 49 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Visual, Pregnancy Hcg, Prescription Use, Radioimmunoassay, Amphetamine, Culture Media, Non-selective And Non-differential, Agglutination Method, Human Chorionic Gonadotropin, Radioimmunoassay, Methaqualone . Use the specialty filter in the sidebar to narrow results.

49 devices
1–25 of 49
BHCG-ROCHE EIA
K850727 · JHI Visual, Pregnancy Hcg,... · Chemistry
Jun 1985 123d
RENAK
K831694 · CIB Radioimmunoassay,... · Chemistry
Jul 1983 56d
ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE
K830460 · DOE Radioimmunoassay,... · Toxicology
Mar 1983 37d
ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE
K830461 · KXS Radioimmunoassay,... · Toxicology
Mar 1983 37d
ABUSCREEN RADIOUMMUNOASSAY--URINE
K830462 · DOE Radioimmunoassay,... · Toxicology
Mar 1983 37d
ABUSCREEN RADIOIMMUNOASSAY-COCAINE META
K830480 · KLN Radioimmunoassay, Cocaine... · Toxicology
Mar 1983 37d
ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE
K830481 · LCL Radioimmunoassay,... · Toxicology
Mar 1983 37d
ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE
K830482 · DJP Radioimmunoassay,... · Toxicology
Mar 1983 37d
ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE
K830479 · DKN Radioimmunoassay,... · Toxicology
Mar 1983 23d
COBAS STANDARDS FOR CREATININE
K823572 · CGX Alkaline Picrate,... · Chemistry
Jan 1983 32d
COBAS REAGENT FOR CREATININE
K823573 · CGX Alkaline Picrate,... · Chemistry
Jan 1983 32d
COBAS REAGENT FOR ALBUMIN
K823574 · CIX Bromcresol Green... · Chemistry
Jan 1983 32d
COBAS STANDARDS FOR ALBUMIN
K823575 · CIX Bromcresol Green... · Chemistry
Jan 1983 32d
COBAS STANDARD FOR TOTAL PROTEIN
K823576 · LER Fluorescent Immunoassay,... · Chemistry
Jan 1983 32d
COBAS REAGENT FOR CALCIUM
K823577 · CIC Cresolphthalein... · Chemistry
Jan 1983 32d
COBAS STANDARDS FOR CALCIUM-IN-ORGANIC
K823578 · CIO Thymolphthalein... · Chemistry
Jan 1983 32d
COBAS REAGENT FOR TOTAL PROTEIN
K823579 · CEK Biuret (colorimetric),... · Chemistry
Jan 1983 32d
COBAS REAGENT FOR INORGANIC PHOSPHORUS
K823580 · CEO Phosphomolybdate... · Chemistry
Jan 1983 32d
HUMAN PLASMA CONTROL FOR CEA-ROCHE
K822219 · JJX Single (specified)... · Immunology
Dec 1982 155d
ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE
K823212 · DJP Radioimmunoassay,... · Chemistry
Nov 1982 32d
ROCHE(R) B-HCG RIA URINE STANDARD
K820942 · JHI Visual, Pregnancy Hcg,... · Chemistry
May 1982 27d
ROCHE B-HCG RIA
K820613 · JHI Visual, Pregnancy Hcg,... · Chemistry
Apr 1982 24d
ROCHE B-HCG STANDARDS
K820614 · JHI Visual, Pregnancy Hcg,... · Chemistry
Apr 1982 24d
ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI
K820391 · LAT Radioimmunoassay,... · Toxicology
Mar 1982 26d
AGGLUTEX AMPHETAMINE TEST KIT
K812986 · DJP Radioimmunoassay,... · Toxicology
Jan 1982 88d
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