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
505–528 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Jan 10, 2005
ONLINE DAT PHENCYCLIDINE PLUS
K043305 · LCM
Roche Diagnostics Corp.
Toxicology · 41d
Cleared Jan 07, 2005
ACETAMINOPHEN-SL ASSAY
K042330 · LDP
Diagnostic Chemicals , Ltd.
Toxicology · 133d
Cleared Jan 07, 2005
EMIT II PLUS ECSTASY ASSAY
K043028 · DKZ
Dade Behring, Inc.
Toxicology · 65d
Cleared Jan 06, 2005
VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS
K042479 · LCD
Ortho-Clinical Diagnostics, Inc.
Toxicology · 115d
Cleared Dec 29, 2004
AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II
K042975 · DIS
Ameditech, Inc.
Toxicology · 62d
Cleared Dec 29, 2004
ONLINE DAT BARBITURATES PLUS
K043211 · DIS
Roche Diagnostics Corp.
Toxicology · 40d
Cleared Dec 27, 2004
SALICYLATE-SL ASSAY
K042329 · DKJ
Diagnostic Chemicals , Ltd.
Toxicology · 122d
Not Cleared Dec 23, 2004
AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
DEN040012 · NSU
Affymetrix, Inc.
Toxicology · 50d
Cleared Nov 30, 2004
VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I,...
K042520 · KLS
Ortho-Clinical Diagnostics, Inc.
Toxicology · 75d
Cleared Nov 23, 2004
RANDOX CANNABINOIDS ASSSAY
K041142 · LDJ
Randox Laboratories, Ltd.
Toxicology · 207d
Cleared Nov 23, 2004
IMPACT TEST SYSTEM
K041746 · DJG
Lifepoint,Inc
Toxicology · 147d
Cleared Nov 05, 2004
RANDOX BARBITURATE ASSAY
K041143 · DIS
Randox Laboratories, Ltd.
Toxicology · 189d
Cleared Nov 03, 2004
RANDOX OPIATES ASSAY
K041144 · DJG
Randox Laboratories, Ltd.
Toxicology · 187d
Cleared Nov 03, 2004
'RAPIDTEC 4' TEST
K041712 · DIS
American Bio Medica Corp.
Toxicology · 133d
Cleared Oct 28, 2004
EMIT CAFFEINE ASSAY
K042407 · KLS
Dade Behring, Inc.
Toxicology · 55d
Cleared Oct 05, 2004
FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
K042651 · JIT
Beckman Coulter, Inc.
Toxicology · 7d
Cleared Sep 09, 2004
ACON TRI-FECT DRUG SCREEN TEST DEVICE
K041743 · DKZ
ACON Laboratories, Inc.
Toxicology · 73d
Cleared Aug 30, 2004
ACON MULTI-CLIN DRUG SCREEN TEST DEVICE
K041685 · DKZ
ACON Laboratories, Inc.
Toxicology · 69d
Cleared Aug 24, 2004
TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM
K032291 · DOA
Linde Medical Sensors AG
Toxicology · 397d
Cleared Aug 17, 2004
DC-ACETA/SAL CONTROLS
K041666 · DIF
Diagnostic Chemicals , Ltd.
Toxicology · 60d
Cleared Aug 11, 2004
ALCOMATE, MODEL CA2000
K041334 · DJZ
Khn Solutions, LLC
Toxicology · 84d
Cleared Jul 13, 2004
ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE...
K041221 · LDJ
Accu-Stat Diagnostics, Inc.
Toxicology · 64d
Cleared Jun 23, 2004
CEDIA BUPRENORPHINE ASSAY
K040316 · DJG
Microgenics Corp.
Toxicology · 135d
Cleared Jun 14, 2004
QUEST DIAGNOSTICS HAIRCHECK-DT (THC)
K040257 · LDJ
Quest Diagnostics, Inc.
Toxicology · 131d