Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

49 results for "Hoffmann-La Roche, Inc."
1–24 of 49
Search insights Median review: 32d Cleared: 100% Top manufacturer: Hoffmann-La Roche, Inc. Lead specialty: Chemistry
Cleared Jun 25, 1985
BHCG-ROCHE EIA
K850727 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 123d
Cleared Jul 19, 1983
RENAK
K831694 · CIB
Hoffmann-La Roche, Inc.
Chemistry · 56d
Cleared Mar 24, 1983
ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE
K830482 · DJP
Hoffmann-La Roche, Inc.
Toxicology · 37d
Cleared Mar 24, 1983
ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE
K830481 · LCL
Hoffmann-La Roche, Inc.
Toxicology · 37d
Cleared Mar 24, 1983
ABUSCREEN RADIOIMMUNOASSAY-COCAINE META
K830480 · KLN
Hoffmann-La Roche, Inc.
Toxicology · 37d
Cleared Mar 24, 1983
ABUSCREEN RADIOUMMUNOASSAY--URINE
K830462 · DOE
Hoffmann-La Roche, Inc.
Toxicology · 37d
Cleared Mar 24, 1983
ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE
K830461 · KXS
Hoffmann-La Roche, Inc.
Toxicology · 37d
Cleared Mar 24, 1983
ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE
K830460 · DOE
Hoffmann-La Roche, Inc.
Toxicology · 37d
Cleared Mar 10, 1983
ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE
K830479 · DKN
Hoffmann-La Roche, Inc.
Toxicology · 23d
Cleared Jan 07, 1983
COBAS REAGENT FOR INORGANIC PHOSPHORUS
K823580 · CEO
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS REAGENT FOR TOTAL PROTEIN
K823579 · CEK
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS STANDARDS FOR CALCIUM-IN-ORGANIC
K823578 · CIO
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS REAGENT FOR CALCIUM
K823577 · CIC
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS STANDARD FOR TOTAL PROTEIN
K823576 · LER
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS STANDARDS FOR ALBUMIN
K823575 · CIX
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS REAGENT FOR ALBUMIN
K823574 · CIX
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS REAGENT FOR CREATININE
K823573 · CGX
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS STANDARDS FOR CREATININE
K823572 · CGX
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Dec 28, 1982
HUMAN PLASMA CONTROL FOR CEA-ROCHE
K822219 · JJX
Hoffmann-La Roche, Inc.
Immunology · 155d
Cleared Nov 29, 1982
ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE
K823212 · DJP
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared May 03, 1982
ROCHE(R) B-HCG RIA URINE STANDARD
K820942 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 27d
Cleared Apr 01, 1982
ROCHE B-HCG STANDARDS
K820614 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 24d
Cleared Apr 01, 1982
ROCHE B-HCG RIA
K820613 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 24d
Cleared Mar 08, 1982
ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI
K820391 · LAT
Hoffmann-La Roche, Inc.
Toxicology · 26d