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
241–264 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Aug 20, 2014
ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD
K140748 · DJG
Co-Innovation Biotech Co., Ltd.
Toxicology · 148d
Cleared Jul 14, 2014
CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE
K141532 · DKZ
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 34d
Cleared Jul 01, 2014
IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE...
K141406 · DJG
Immunalysis Corporation
Toxicology · 34d
Cleared Jun 16, 2014
ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD
K140215 · DIS
Co-Innovation Biotech Co., Ltd.
Toxicology · 139d
Cleared Jun 13, 2014
LZI HYDROCODONE
K141055 · DJG
Lin-Zhi International, Inc.
Toxicology · 50d
Cleared May 14, 2014
QUICKSCREEN AMPHETINE 500 TEST
K131069 · DKZ
Phamatech, Inc.
Toxicology · 392d
Cleared Apr 08, 2014
CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO)
K140089 · DJG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 84d
Cleared Mar 21, 2014
LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
K131652 · LAF
Lin-Zhi International, Inc.
Toxicology · 289d
Cleared Mar 06, 2014
UCP MULTI-DRUG TEST KEY CUPS
K132812 · DKZ
Ucp Biosciences, Inc.
Toxicology · 178d
Cleared Feb 26, 2014
STATUS DS OXY
K130650 · DJG
Princeton BioMeditech Corp.
Toxicology · 352d
Cleared Feb 21, 2014
LZI MULTIPLE ANALYTE SET A
K133710 · DKB
Lin-Zhi International, Inc.
Toxicology · 79d
Cleared Feb 04, 2014
LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
K131653 · DKZ
Lin-Zhi International, Inc.
Toxicology · 244d
Cleared Jan 24, 2014
RAPIDFRET ORAL FLUID ASSAY FOR OPIATES
K133642 · DJG
Biophor Diagnostics, Inc.
Toxicology · 58d
Cleared Jan 17, 2014
IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY
K131168 · DJG
Immunalysis Corporation
Toxicology · 268d
Cleared Jan 15, 2014
ONE STEP SINGLE/MULTI-DRUG TEST CUP
K131110 · DKZ
Co-Innovation Biotech Co., Ltd.
Toxicology · 271d
Cleared Dec 16, 2013
SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL,...
K132688 · DIF
Biochemical Diagnostics, Inc.
Toxicology · 110d
Cleared Nov 13, 2013
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
K131128 · DIO
Omega Laboratories, Inc.
Toxicology · 204d
Cleared Oct 18, 2013
RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET,...
K132096 · LDJ
Biophor Diagnostics, Inc.
Toxicology · 102d
Cleared Oct 07, 2013
INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)
K131645 · DKZ
Alfa Scientific Designs, Inc.
Toxicology · 124d
Cleared Sep 27, 2013
WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST...
K132630 · DJC
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 36d
Cleared Sep 26, 2013
QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST
K130275 · DJG
Tianjin New Bay Bioresearch Co., Ltd.
Toxicology · 234d
Cleared Sep 20, 2013
MULTICHEM WBT
K132174 · DIF
Techno-Path Manufacturing , Ltd.
Toxicology · 67d
Cleared Sep 11, 2013
XTAG CYP2C19 KIT V3
K131565 · NTI
Luminex Molecular Diagnostics, Inc.
Toxicology · 104d
Cleared Aug 29, 2013
ARCHITECT IVANCOMYCIN
K123947 · LEH
Biokit, S.A.
Toxicology · 251d