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
697–720 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Dec 18, 2001
ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE
K013380 · DJG
ACON Laboratories, Inc.
Toxicology · 67d
Cleared Dec 14, 2001
ETHANOL
K013538 · DML
Abbott Laboratories
Toxicology · 51d
Cleared Dec 12, 2001
SYNCHRON SYSTEMS VANCOMYCIN REAGENT
K013076 · LEH
Beckman Coulter, Inc.
Toxicology · 89d
Cleared Dec 06, 2001
AT HOME DRUG TEST, MODEL 9084
K013407 · DJG
Phamatech, Inc.
Toxicology · 52d
Cleared Dec 06, 2001
AT HOME DRUG TEST, MODEL 9079
K013408 · DJG
Phamatech, Inc.
Toxicology · 52d
Cleared Dec 06, 2001
AT HOME DRUG TEST, MODEL 9074
K013409 · MVO
Phamatech, Inc.
Toxicology · 52d
Cleared Dec 06, 2001
AT HOME DRUG TEST, MODEL 9064
K013410 · MVO
Phamatech, Inc.
Toxicology · 52d
Cleared Dec 06, 2001
AT HOME DRUG TEST, MODEL 9069
K013412 · MVO
Phamatech, Inc.
Toxicology · 52d
Cleared Dec 04, 2001
RANDOX PHENYTOIN
K011393 · DIP
Randox Laboratories, Ltd.
Toxicology · 211d
Cleared Nov 30, 2001
AMEDITECH IMMUTEST DRUG SCREEN OPIATES
K012483 · DJG
Ameditech, Inc.
Toxicology · 120d
Cleared Nov 30, 2001
AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE
K012484 · DKZ
Ameditech, Inc.
Toxicology · 120d
Cleared Nov 30, 2001
AMEDITECH IMMUTEST DRUG SCREEN PCP
K012582 · LCM
Ameditech, Inc.
Toxicology · 112d
Cleared Nov 26, 2001
RAPIDONE-ECSTASY TEST
K013180 · DJC
American Bio Medica Corp.
Toxicology · 63d
Cleared Nov 26, 2001
LIVESURE METHADONE SCREEN TESTS
K013796 · DJR
Pan Probe Biotech, Inc.
Toxicology · 11d
Cleared Nov 20, 2001
'RAPIDONE'-METHADONE TEST
K012164 · DJR
American Bio Medica Corp.
Toxicology · 132d
Cleared Nov 16, 2001
AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE
K012585 · LAF
Ameditech, Inc.
Toxicology · 98d
Cleared Nov 09, 2001
ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES...
K012824 · DIS
ACON Laboratories, Inc.
Toxicology · 78d
Cleared Nov 07, 2001
MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP
K013124 · DJJ
Branan Medical Corp.
Toxicology · 49d
Cleared Nov 06, 2001
PSYCHEMEDICS RIA COCAINE ASSAY
K010868 · KLN
Psychemedics Corp.
Toxicology · 228d
Cleared Nov 05, 2001
ONTRAK TESTCARD 9
K012396 · DKZ
Roche Diagnostics Corp.
Toxicology · 101d
Cleared Oct 25, 2001
DRUGS OF ABUSE MULTI-TEST STRIP
K011952 · DKZ
Microdiagnostics, Inc.
Toxicology · 126d
Cleared Oct 22, 2001
AMEDITECH IMMUTEST DRUG SCREEN THC
K011813 · LDJ
Ameditech, Inc.
Toxicology · 133d
Cleared Oct 22, 2001
AMEDITECH IMMUTEST DRUG SCREEN COC
K011814 · DIO
Ameditech, Inc.
Toxicology · 133d
Cleared Oct 15, 2001
ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE
K012595 · DJR
ACON Laboratories, Inc.
Toxicology · 66d