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."
217–240 of 296
Search insights Median review: 66d Cleared: 100% Top manufacturer: Roche Diagnostic Systems, Inc. Lead specialty: Toxicology
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR MORPHINE
K893856 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR BARBITUATES
K893855 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
COBAS FARA II CENTRIFUGAL ANALYZER
K893854 · JJG
Roche Diagnostic Systems, Inc.
Chemistry · 70d
Cleared Jul 20, 1989
COBAS FARA CENTRIFUGAL ANALYZER
K893641 · JJG
Roche Diagnostic Systems, Inc.
Chemistry · 66d
Cleared May 22, 1989
ROCHE(R) CARDIOSCREEN-CK
K891462 · CGS
Roche Diagnostic Systems, Inc.
Chemistry · 68d
Cleared Mar 31, 1989
ABUSCREEN FP BENZODIAZEPHINE REAGENT
K891697 · JXM
Roche Diagnostic Systems, Inc.
Toxicology · 9d
Cleared Mar 31, 1989
ROCHE CHLORIDE ELECTRODE
K890528 · CGA
Roche Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Mar 22, 1989
COBAS MFC
K885292 · JQP
Roche Diagnostic Systems, Inc.
Chemistry · 85d
Cleared Mar 16, 1989
ABUSCREEN FP FOR CANNABINOIDS
K890887 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 23d
Cleared Mar 15, 1989
ABUSCREEN FP FOR MORPHINE
K890888 · DJG
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Mar 15, 1989
ABUSCREEN FP BUFFER REAGENT
K890883 · DIO
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Mar 15, 1989
ABUSCREEN FP FOR PHENCYCLIDINE
K890882 · LCL
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Mar 13, 1989
ABUSCREEN FP FOR COCAINE METABOLITE
K890885 · DIO
Roche Diagnostic Systems, Inc.
Toxicology · 20d
Cleared Mar 10, 1989
ABUSCREEN FP FOR AMPHETAMINE
K890886 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 17d
Cleared Mar 09, 1989
ABUSCREEN FP FOR BARBITURATES
K890884 · DIS
Roche Diagnostic Systems, Inc.
Toxicology · 16d
Cleared Dec 09, 1988
ROCHE REAGENT FOR CHLORIDE
K884013 · CHJ
Roche Diagnostic Systems, Inc.
Chemistry · 78d
Cleared Nov 29, 1988
ROCHE REAGENT FOR INORGANIC PHOSPHORUS
K883962 · CEO
Roche Diagnostic Systems, Inc.
Chemistry · 70d
Cleared Oct 25, 1988
ROCHE REAGENT FOR CALCIUM
K883453 · CJY
Roche Diagnostic Systems, Inc.
Chemistry · 74d
Cleared Sep 02, 1988
ABUSCREEN(R) ONTRAK(TM) FOR MORPHINE
K882496 · DJG
Roche Diagnostic Systems, Inc.
Toxicology · 77d
Cleared Jul 29, 1988
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES
K881817 · DJP
Roche Diagnostic Systems, Inc.
Toxicology · 92d
Cleared Jul 29, 1988
ABUSCREEN(R) ONTRAK(TM) FOR COCAINE
K881815 · DIO
Roche Diagnostic Systems, Inc.
Toxicology · 92d
Cleared Jul 29, 1988
ABUSCREEN(R) ONTRAK(TM) FOR THC
K881814 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 92d
Cleared Jul 28, 1988
ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES
K881816 · DKN
Roche Diagnostic Systems, Inc.
Toxicology · 91d
Cleared Jun 10, 1988
COBAS EIA(TM) PHOTOMETER
K881877 · JJQ
Roche Diagnostic Systems, Inc.
Chemistry · 37d