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."
1–24 of 296
Search insights Median review: 66d Cleared: 100% Top manufacturer: Roche Diagnostic Systems, Inc. Lead specialty: Toxicology
Cleared May 03, 1999
MODIFICATION TO ABUSCREEN ONLINE BARBITURATES
K983698 · DIS
Roche Diagnostic Systems, Inc.
Toxicology · 194d
Cleared Feb 11, 1999
MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES
K983702 · JXM
Roche Diagnostic Systems, Inc.
Toxicology · 113d
Cleared Feb 10, 1999
MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE
K983704 · JCM
Roche Diagnostic Systems, Inc.
Toxicology · 112d
Cleared Dec 15, 1998
ABUSCREEN ONLINE BENZ 300 CALIBRATORS
K983556 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 63d
Cleared Dec 15, 1998
ABUSCREEN ONLINE BENZ 200 CALIBRATORS
K983555 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 63d
Cleared Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE
K983703 · DJR
Roche Diagnostic Systems, Inc.
Toxicology · 51d
Cleared Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS
K983701 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 51d
Cleared Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE
K983700 · JXN
Roche Diagnostic Systems, Inc.
Toxicology · 51d
Cleared Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES
K983699 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 51d
Cleared Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE
K983697 · DIO
Roche Diagnostic Systems, Inc.
Toxicology · 51d
Cleared Nov 18, 1998
ONTRAK TESTCUP-ER
K983388 · DIO
Roche Diagnostic Systems, Inc.
Toxicology · 54d
Cleared Nov 18, 1998
ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES
K983174 · JXM
Roche Diagnostic Systems, Inc.
Toxicology · 69d
Cleared Oct 09, 1998
ONTRAK TESTCUP AND TESTSTIK CONTROLS
K983387 · DIF
Roche Diagnostic Systems, Inc.
Chemistry · 14d
Cleared Oct 01, 1998
COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT
K982848 · MRR
Roche Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Sep 28, 1998
COBAS INTEGRA REAGENT CASSETTES
K982382 · CFN
Roche Diagnostic Systems, Inc.
Immunology · 82d
Cleared Aug 26, 1998
ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE...
K981897 · CJE
Roche Diagnostic Systems, Inc.
Chemistry · 86d
Cleared Aug 18, 1998
ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE...
K982551 · DIS
Roche Diagnostic Systems, Inc.
Toxicology · 27d
Cleared Aug 18, 1998
ROCHE CRP T CONTROL N
K982087 · DCK
Roche Diagnostic Systems, Inc.
Immunology · 64d
Cleared Jun 05, 1998
COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)
K980996 · KHS
Roche Diagnostic Systems, Inc.
Chemistry · 80d
Cleared May 28, 1998
ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT)
K981585 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared May 28, 1998
ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT)
K981584 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared May 21, 1998
COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA...
K974695 · CKB
Roche Diagnostic Systems, Inc.
Chemistry · 156d
Cleared Apr 24, 1998
ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES...
K974840 · DJG
Roche Diagnostic Systems, Inc.
Toxicology · 121d
Cleared Dec 18, 1997
COBAS INTEGRA HDL-CHOLESTEROL DIRECT
K973284 · CHH
Roche Diagnostic Systems, Inc.
Chemistry · 107d