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
793–816 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Apr 05, 2001
VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO
K010564 · DKZ
Medtox Diagnostics, Inc.
Toxicology · 38d
Cleared Apr 05, 2001
AT HOME DRUG TEST, MODEL 9068 T
K010653 · MVO
Phamatech
Toxicology · 31d
Cleared Apr 05, 2001
AT HOME DRUG TEST, MODEL 9078 T
K010654 · MVO
Phamatech
Toxicology · 31d
Cleared Apr 05, 2001
AT HOME DRUG TESTT, MODEL 9150 T
K010655 · MVO
Phamatech
Toxicology · 31d
Cleared Mar 30, 2001
AT HOME DRUG TEST, MODEL 9063 T
K010645 · DKZ
Phamatech
Toxicology · 25d
Cleared Mar 30, 2001
AT HOME DRUG TEST, MODEL 9083 T
K010646 · MVO
Phamatech
Toxicology · 25d
Cleared Mar 30, 2001
AT HOME DRUG TEST, MODEL 9073 T
K010650 · DIO
Phamatech
Toxicology · 25d
Cleared Mar 30, 2001
AT HOME DRUG TEST, MODEL 9133 T
K010651 · LCM
Phamatech
Toxicology · 25d
Cleared Mar 20, 2001
ESCREEN SYSTEM
K003352 · LAF
Escreen, Inc.
Toxicology · 145d
Cleared Mar 15, 2001
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE)
K003557 · LDJ
ACON Laboratories, Inc.
Toxicology · 118d
Cleared Mar 08, 2001
MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12
K004034 · DKZ
Branan Medical Corp.
Toxicology · 70d
Cleared Feb 28, 2001
COBAS INTEGRA AMPHETAMINES
K003865 · DKZ
Roche Diagnostics Corp.
Toxicology · 77d
Cleared Feb 14, 2001
PROFILE II ER
K010138 · LDJ
Medtox Diagnostics, Inc.
Toxicology · 28d
Cleared Feb 12, 2001
MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175
K003858 · MVO
Phamatech
Toxicology · 61d
Cleared Feb 05, 2001
IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2
K003597 · LPS
Diagnostic Products Corp.
Toxicology · 76d
Cleared Feb 05, 2001
LIVESURE THC SCREEN TEST
K010001 · LDJ
Pan Probe Biotech, Inc.
Toxicology · 34d
Cleared Jan 26, 2001
STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
K002375 · LDJ
OraSure Technologies, Inc.
Toxicology · 175d
Cleared Jan 22, 2001
ADVANTAGE THC/COCAINE TEST
K003708 · DIO
Advantage Diagnostics Corp.
Toxicology · 52d
Cleared Jan 17, 2001
PROFILE-ER
K002331 · DIS
Medtox Diagnostics, Inc.
Toxicology · 169d
Cleared Dec 22, 2000
VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II...
K003687 · DKE
Medtox Diagnostics, Inc.
Toxicology · 22d
Cleared Dec 11, 2000
PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR
K000851 · DJG
Psychemedics Corp.
Toxicology · 271d
Cleared Dec 06, 2000
STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
K001976 · DIS
OraSure Technologies, Inc.
Toxicology · 160d
Cleared Dec 05, 2000
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A
K003209 · DJG
Dade Behring, Inc.
Toxicology · 53d
Cleared Nov 29, 2000
STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421
K002010 · DJR
OraSure Technologies, Inc.
Toxicology · 149d