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

Filters: Toxicology ×
3,029 results
985–1008 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Feb 26, 1999
ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544,...
K990377 · DIF
Roche Diagnostics Corp.
Toxicology · 18d
Cleared Feb 23, 1999
ONTRAK TESTCUP-5 M2K
K990337 · DKZ
Roche Diagnostics Corp.
Toxicology · 20d
Cleared Feb 16, 1999
DIMENSION DRUG CALIBRATOR II, MODEL DC49B
K990255 · DKB
Dade Behring, Inc.
Toxicology · 20d
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 Feb 05, 1999
QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO...
K982938 · DJR
Phamatech
Toxicology · 168d
Cleared Jan 29, 1999
SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT
K984152 · DJG
Beckman Coulter, Inc.
Toxicology · 71d
Cleared Jan 26, 1999
VITROS CHEMISTRY PRODUCTS PHBR SLIDES
K984288 · DLZ
Ortho-Clinical Diagnostics, Inc.
Toxicology · 56d
Cleared Jan 22, 1999
MODIFICATION OF EMIT D.A.U. OPIATES ASSAY
K984232 · DJG
Syva Co.
Toxicology · 58d
Cleared Dec 30, 1998
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II
K983747 · DKB
Beckman Coulter, Inc.
Toxicology · 68d
Cleared Dec 22, 1998
ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST
K981363 · LCM
Tcpi, Inc.
Toxicology · 251d
Cleared Dec 18, 1998
ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN...
K983501 · LAG
Princeton BioMeditech Corp.
Toxicology · 73d
Cleared Dec 15, 1998
ABUSCREEN ONLINE BENZ 200 CALIBRATORS
K983555 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 63d
Cleared Dec 15, 1998
ABUSCREEN ONLINE BENZ 300 CALIBRATORS
K983556 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 63d
Cleared Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE
K983697 · DIO
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 FOR PROPOXYPHENE
K983700 · JXN
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 METHADONE
K983703 · DJR
Roche Diagnostic Systems, Inc.
Toxicology · 51d
Cleared Nov 20, 1998
AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U
K982759 · DIO
OraSure Technologies, Inc.
Toxicology · 106d
Cleared Nov 18, 1998
AUTO-LYTE BARBITURATES EIA
K982745 · DIS
OraSure Technologies, Inc.
Toxicology · 104d
Cleared Nov 18, 1998
ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES
K983174 · JXM
Roche Diagnostic Systems, Inc.
Toxicology · 69d
Cleared Nov 18, 1998
DBEST TETRAHYDROCANNABINOL TEST KIT
K983188 · LDJ
Ameritek, Inc.
Toxicology · 68d
Cleared Nov 18, 1998
DBEST METHAMPHETAMINES TEST KIT
K983189 · LAF
Ameritek, Inc.
Toxicology · 68d