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
673–696 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Mar 20, 2002
PROPOXYPHENE
K013100 · JXN
Abbott Laboratories
Toxicology · 184d
Cleared Mar 20, 2002
RAPIDONE-OXY TEST
K014101 · DJG
American Bio Medica Corp.
Toxicology · 97d
Cleared Mar 20, 2002
VISUALINE BARBITURATES DIPSTRIP TEST
K020136 · DIS
Sun Biomedical Laboratories, Inc.
Toxicology · 64d
Cleared Mar 19, 2002
KAYAK HYDROPHILIC GUIDE WIRES
K014195 · DOX
Boston Scientific Corp
Toxicology · 88d
Cleared Mar 13, 2002
AMPHETAMINE/METHAMPHETAMINE
K012998 · LAF
Abbott Laboratories
Toxicology · 188d
Cleared Mar 13, 2002
COCAINE
K013004 · DIO
Abbott Laboratories
Toxicology · 188d
Cleared Mar 13, 2002
PHENCYCLIDINE
K013096 · LCM
Abbott Laboratories
Toxicology · 177d
Cleared Mar 13, 2002
BENZODIAZEPINES
K013143 · JXM
Abbott Laboratories
Toxicology · 174d
Cleared Mar 13, 2002
CANNABINOIDS
K013247 · LDJ
Abbott Laboratories
Toxicology · 166d
Cleared Mar 13, 2002
OPIATES
K013314 · DJG
Abbott Laboratories
Toxicology · 160d
Cleared Feb 15, 2002
SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR
K014173 · DKJ
Beckman Coulter, Inc.
Toxicology · 57d
Cleared Feb 11, 2002
PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY
K011275 · LCL
Psychemedics Corp.
Toxicology · 291d
Cleared Feb 07, 2002
PEACE OF MIND HOME DRUG TEST
K013778 · MVO
Advantage Diagnostics Corp.
Toxicology · 86d
Cleared Jan 29, 2002
BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS
K013959 · DKB
Bayer Diagnostics Corp.
Toxicology · 60d
Cleared Jan 24, 2002
PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY
K011185 · DJC
Psychemedics Corp.
Toxicology · 281d
Cleared Jan 24, 2002
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE...
K013899 · CDD
Ortho-Clinical Diagnostics
Toxicology · 62d
Cleared Jan 15, 2002
RANDOX CARBAMAZEPINE
K011648 · KLT
Randox Laboratories, Ltd.
Toxicology · 231d
Cleared Jan 15, 2002
RANDOX VALPROIC ACID
K011649 · LEG
Randox Laboratories, Ltd.
Toxicology · 231d
Cleared Jan 11, 2002
RANDOX DIGITOXIN
K012112 · LFM
Randox Laboratories, Ltd.
Toxicology · 189d
Cleared Jan 10, 2002
TRIAGE TOX DRUG SCREEN, CATALOG #94000
K012745 · DKZ
Biosite Incorporated
Toxicology · 147d
Cleared Jan 08, 2002
ROCHE ACETAMINOPHEN
K013757 · LDP
Roche Diagnostics Corp.
Toxicology · 56d
Cleared Dec 21, 2001
ABUSCREEN ONLINE OPIATES 300 / 2000
K013482 · DJG
Roche Diagnostics Corp.
Toxicology · 63d
Cleared Dec 21, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS
K013900 · JJX
Ortho-Clinical Diagnostics
Toxicology · 28d
Cleared Dec 18, 2001
NO STEP ON SITE DEUG TEST CUP
K012390 · LDJ
Drug Free Enterprises
Toxicology · 144d