FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Toxicology ×
3,027 results
793–816 of 3,027
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
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
Cleared Nov 29, 2000
FIRST CHECK HOME DRUG TEST PANEL 4
K993852 · LAF
Worldwide Medical Corp.
Toxicology · 383d
Cleared Nov 27, 2000
BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST
K002263 · LDJ
Branan Medical Corp.
Toxicology · 125d