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."
121–144 of 296
Search insights Median review: 66d Cleared: 100% Top manufacturer: Roche Diagnostic Systems, Inc. Lead specialty: Toxicology
Cleared Jun 16, 1992
ROCHE CALIBRATOR SERUM
K922043 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 46d
Cleared May 26, 1992
ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED
K921998 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 33d
Cleared Apr 29, 1992
ROCHE COBAS MIRA PLUS
K920402 · JJE
Roche Diagnostic Systems, Inc.
Chemistry · 89d
Cleared Mar 18, 1992
ABUSCREEN ONLINE FOR PHENCYCLIDINE
K920935 · LCM
Roche Diagnostic Systems, Inc.
Toxicology · 19d
Cleared Jan 28, 1992
ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL
K915516 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Nov 22, 1991
ROCHE COBAS(R) AMMONIA AND ETHANOL CALIBRATOR
K914750 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 31d
Cleared Nov 19, 1991
ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL
K914806 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 26d
Cleared Nov 01, 1991
ABUSCREEN(R) ONLINE(TM) FOR BENZODIAZEPINES
K914509 · JXM
Roche Diagnostic Systems, Inc.
Toxicology · 23d
Cleared Nov 01, 1991
ABUSCREEN(R) RADIOIMMUNOASSAY FOR METHAMPHE/AMPHET
K913911 · DPJ
Roche Diagnostic Systems, Inc.
Toxicology · 63d
Cleared Oct 30, 1991
ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES
K914468 · DKN
Roche Diagnostic Systems, Inc.
Toxicology · 23d
Cleared Sep 27, 1991
ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE
K912754 · DPJ
Roche Diagnostic Systems, Inc.
Toxicology · 98d
Cleared Sep 27, 1991
ROCHE COBAS ARGOS 5 DIFF
K912615 · GZI
Roche Diagnostic Systems, Inc.
Hematology · 106d
Cleared Sep 25, 1991
ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT
K913414 · LAT
Roche Diagnostic Systems, Inc.
Toxicology · 62d
Cleared Sep 10, 1991
ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE
K913722 · KLN
Roche Diagnostic Systems, Inc.
Toxicology · 25d
Cleared Aug 26, 1991
ABUSCREEN(R) ONLINE(TM) CONTROLS
K913336 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 34d
Cleared Aug 26, 1991
ABUSCREEN(R) ONLINE(TM) CALIBRATORS
K913335 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 34d
Cleared Aug 26, 1991
ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE
K912755 · DJP
Roche Diagnostic Systems, Inc.
Toxicology · 66d
Cleared Aug 12, 1991
ROCHE REAGENT FOR ETHANOL
K913125 · DIC
Roche Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Aug 12, 1991
ROCHE REAGENT FOR AMMONIA
K913124 · JIF
Roche Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Aug 12, 1991
ABUSCREEN(R) ONTRAK(R) POSITIVE REF CONT BENZODIAZ
K913107 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 31d
Cleared Aug 12, 1991
ABUSCREEN ONLINE FOR THC (50 AND 100)
K912574 · LAT
Roche Diagnostic Systems, Inc.
Toxicology · 61d
Cleared Jul 26, 1991
ABUSCREEN ONLINE FOR AMPHETAMINES
K912758 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 35d
Cleared Jul 26, 1991
ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS
K912757 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 35d
Cleared Jul 26, 1991
ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE
K912756 · KLN
Roche Diagnostic Systems, Inc.
Toxicology · 35d