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

296 results for "Roche Diagnostic Systems, Inc."
145–168 of 296
Search insights Median review: 66d Cleared: 100% Top manufacturer: Roche Diagnostic Systems, Inc. Lead specialty: Toxicology
Cleared Jul 26, 1991
ABUSCREEN(R) ONLINE(TM) THC CALIBRATORS
K912048 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 78d
Cleared Jul 19, 1991
ROCHE REAGENT FOR C02
K911838 · CHS
Roche Diagnostic Systems, Inc.
Chemistry · 85d
Cleared Jun 21, 1991
ABUSCREEN FP FOR CANNABINOIDS (15-50)
K910592 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 129d
Cleared May 08, 1991
ROCHE APOLIPOPROTEIN STANDARD
K910553 · DER
Roche Diagnostic Systems, Inc.
Immunology · 90d
Cleared May 07, 1991
ROCHE REAGENT FOR APOLIPOPROTEIN B
K910552 · MSJ
Roche Diagnostic Systems, Inc.
Immunology · 89d
Cleared May 07, 1991
ROCHE REAGENT FOR APOLIPOPROTEIN A-1
K910551 · MSJ
Roche Diagnostic Systems, Inc.
Immunology · 89d
Cleared Apr 24, 1991
ROCHE REAGENT FOR DIRECT BILIRUBIN
K910593 · CIG
Roche Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Apr 24, 1991
ROCHE REAGENT FOR TOTAL BILIRUBIN
K910591 · CIG
Roche Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Apr 05, 1991
ABUSCREEN ONTRAK FOR BENZODIAZEPINE
K910590 · JXM
Roche Diagnostic Systems, Inc.
Toxicology · 52d
Cleared Apr 03, 1991
ABUSCREEN ONTRAK FOR METHAMPHETAMINE
K910658 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 48d
Cleared Apr 03, 1991
ABUSCREEN FP FOR CANNABINOIDS (50-100)
K910589 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Apr 03, 1991
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINE(500 NG/ML)
K910278 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Mar 11, 1991
ABUSCREEN(R) FP FOR METHAMPHETAMINE (500-1000)
K910756 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 20d
Cleared Mar 11, 1991
ABUSCREEN(R) ONLINE CONTROLS
K910689 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 20d
Cleared Mar 11, 1991
ABUSCREEN ONLINE CANNABINOIDS CALIBRATORS
K910085 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 62d
Cleared Feb 27, 1991
COBAS ALPHA
K910222 · JJG
Roche Diagnostic Systems, Inc.
Toxicology · 40d
Cleared Feb 04, 1991
ABUSCREEN ONLINE OPIATES CALIBRATORS
K910087 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 27d
Cleared Feb 04, 1991
ABUSCREEN(R) ONLINE CALIBRATORS
K905828 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 48d
Cleared Jan 17, 1991
ABUSCREEN ONLINE COCAINE METABOLITE CALIBRATORS
K910086 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 9d
Cleared Jan 15, 1991
ABUSCREEN ONTRAK FOR COCAINE (200NG/ML)
K905730 · KLN
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Jan 11, 1991
ABUSCREEN ONLINE TM FOR THC
K904996 · LAT
Roche Diagnostic Systems, Inc.
Toxicology · 65d
Cleared Dec 27, 1990
ABUSCREEN ONLINE TM FOR OPIATES
K904997 · DJG
Roche Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Dec 13, 1990
ABUSCREEN ONTRAK FOR THC
K904856 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 45d
Cleared Nov 28, 1990
ABUSCREEN ONLINE TM FOR COCAINE METABOLITE
K904995 · KLN
Roche Diagnostic Systems, Inc.
Toxicology · 21d