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."
25–48 of 49
Search insights Median review: 32d Cleared: 100% Top manufacturer: Hoffmann-La Roche, Inc. Lead specialty: Chemistry
Cleared Jan 22, 1982
AGGLUTEX AMPHETAMINE TEST KIT
K812986 · DJP
Hoffmann-La Roche, Inc.
Toxicology · 88d
Cleared Dec 31, 1981
AGGLUTEX BARBITURATES TEST KIT
K812988 · DKN
Hoffmann-La Roche, Inc.
Toxicology · 66d
Cleared Dec 31, 1981
AGGLUTEX MORPHINE TEST KIT
K812985 · DDF
Hoffmann-La Roche, Inc.
Toxicology · 66d
Cleared Dec 22, 1981
AGGLUTEX METHAQUALONE TEST KIT
K812987 · KXS
Hoffmann-La Roche, Inc.
Toxicology · 57d
Cleared Oct 23, 1981
SEPTI-CHEK COLUMBIA BROTH BLOOD CULTURE
K812730 · JSG
Hoffmann-La Roche, Inc.
Microbiology · 25d
Cleared Oct 19, 1981
SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE
K812732 · JSG
Hoffmann-La Roche, Inc.
Microbiology · 21d
Cleared Oct 19, 1981
SEPTI-CHECK BLOOD CULTURE SLIDE
K812731 · JSI
Hoffmann-La Roche, Inc.
Microbiology · 21d
Cleared Oct 19, 1981
SEPTI-CHEK BLOOD CULTURE BOTTLE ROCHE
K812729 · JSG
Hoffmann-La Roche, Inc.
Microbiology · 21d
Cleared May 13, 1981
HCG RADIOIMMUNOASSAY
K811116 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 19d
Cleared Apr 14, 1981
ISOMUNE-CK
K810905 · JHW
Hoffmann-La Roche, Inc.
Chemistry · 11d
Cleared Jun 20, 1980
ROCHE HCG STANDARDS
K801244 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 24d
Cleared Jan 17, 1980
COBAS-BIO CENTRIFUGAL ANALYZER
K792671 · JJG
Hoffmann-La Roche, Inc.
Chemistry · 21d
Cleared Jan 17, 1980
COBAS-BLO REAGENTS (LACTATE DEHYDRO
K792658 · CFJ
Hoffmann-La Roche, Inc.
Chemistry · 22d
Cleared Jan 16, 1980
SENSI-SLIDE
K792657 · JHJ
Hoffmann-La Roche, Inc.
Chemistry · 21d
Cleared Oct 26, 1979
ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS
K791373 · CFE
Hoffmann-La Roche, Inc.
Chemistry · 94d
Cleared Jul 30, 1979
HCG RIA PREGNANCY TEST
K791206 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 31d
Cleared Jun 15, 1979
ABUSCREEN RIA FOR PHENCYCLIDINE
K790655 · LCL
Hoffmann-La Roche, Inc.
Toxicology · 71d
Cleared May 03, 1979
AMYLOCHROME STAT SEPARATOR, TEST
K790485 · JKA
Hoffmann-La Roche, Inc.
Chemistry · 52d
Cleared Apr 04, 1979
CPK-CS
K790357 · JHT
Hoffmann-La Roche, Inc.
Chemistry · 40d
Cleared Mar 21, 1979
SENSI-TEX
K790267 · JHJ
Hoffmann-La Roche, Inc.
Chemistry · 43d
Cleared Aug 31, 1978
ENTEROTUBE II
K781236 · JSS
Hoffmann-La Roche, Inc.
Microbiology · 42d
Cleared Mar 30, 1978
ROCHE TSH RIA
K780428 · JLW
Hoffmann-La Roche, Inc.
Chemistry · 13d
Cleared Sep 20, 1977
T3 RIA
K771623 · CDP
Hoffmann-La Roche, Inc.
Toxicology · 26d
Cleared Apr 27, 1977
IN VITRO DIAGNOSTIC TEST
K770467
Hoffmann-La Roche, Inc.
Immunology · 48d