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
289–312 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Nov 29, 2012
CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS
K123080 · JXM
Chemtron Biotech, Inc.
Toxicology · 59d
Cleared Nov 15, 2012
WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU
K122904 · DKZ
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 55d
Cleared Nov 06, 2012
VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)
K120466 · NTI
Nanosphere, Inc.
Toxicology · 265d
Cleared Sep 12, 2012
ALCO-SCREEN 02
K121256 · DIC
Chematics, Inc.
Toxicology · 140d
Cleared Jun 01, 2012
LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI...
K120763 · DJG
Lin-Zhi International, Inc.
Toxicology · 80d
Cleared May 17, 2012
CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS
K121339 · DKZ
Chemtron Biotech, Inc.
Toxicology · 14d
Cleared May 14, 2012
TINA-QUANT ALBUMIN GEN.2
K113072 · DCF
Roche Diagnostics Operations
Toxicology · 210d
Cleared May 08, 2012
LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS,...
K120761 · DJG
Lin-Zhi International, Inc.
Toxicology · 56d
Cleared May 08, 2012
WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL
K121166 · DIO
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 21d
Cleared May 01, 2012
PSYCHEMEDICS COCAINE EIA
K111925 · JXO
Psychemedics Corp.
Toxicology · 300d
Cleared May 01, 2012
PSYCHEMEDICS OPIATES EIA
K111926 · DJG
Psychemedics Corp.
Toxicology · 300d
Cleared May 01, 2012
PSYCHEMEDICS CANNABINOIDS EIA
K111929 · LDJ
Psychemedics Corp.
Toxicology · 300d
Cleared Apr 18, 2012
WUNDER TEST
K102428 · LDJ
Hien Helen Nguyen
Toxicology · 601d
Cleared Apr 11, 2012
ORATECT ORAL FLUID DRUG SCREEN DEVICES
K103227 · DIO
Branan Medical Corporation
Toxicology · 527d
Cleared Feb 01, 2012
QUICKSCREEN COCAINE 150 SCREENING TEST
K103295 · DIO
Phamatech, Inc.
Toxicology · 450d
Cleared Jan 23, 2012
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
K112808 · DIO
Omega Laboratories, Inc.
Toxicology · 118d
Cleared Dec 13, 2011
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES
K103161 · DJG
Omega Laboratories, Inc.
Toxicology · 412d
Cleared Dec 05, 2011
AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)
K113501 · DIO
Ameditech, Inc.
Toxicology · 10d
Cleared Nov 15, 2011
ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL
K111005 · DIC
Medica Corp.
Toxicology · 218d
Cleared Nov 10, 2011
AMEDITECH IMMUTEST MILTI-DRUG SCREEN
K113046 · DKZ
Ameditech, Inc.
Toxicology · 28d
Cleared Oct 18, 2011
ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE...
K111904 · LAO
ARK Diagnostics, Inc.
Toxicology · 105d
Cleared Oct 14, 2011
ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS
K103627 · KLT
Abbott Laboratories
Toxicology · 305d
Cleared Sep 14, 2011
CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD
K111322 · JXM
Chemtron Biotech, Inc.
Toxicology · 126d
Cleared Sep 09, 2011
WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST
K112395 · LFG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 21d