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
769–792 of 3,027
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared May 29, 2001
INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST
K010125 · DIS
Alfa Scientific Designs, Inc.
Toxicology · 183d
Cleared May 29, 2001
CEDIA DAU AMPHETAMINES/ECSTASY ASSAY
K010496 · LAF
Microgenics Corp.
Toxicology · 97d
Cleared May 17, 2001
VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY
K010177 · DKZ
Sun Biomedical Laboratories, Inc.
Toxicology · 119d
Cleared May 17, 2001
EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229
K011300 · LDJ
Syva Co., Dade Behring, Inc.
Toxicology · 17d
Cleared May 17, 2001
EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
K011347 · DIP
Syva Co.
Toxicology · 15d
Cleared May 16, 2001
EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229
K011306 · JXM
Syva Co., Dade Behring, Inc.
Toxicology · 16d
Cleared May 15, 2001
MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229
K011161 · LCM
Syva Co., Dade Behring, Inc.
Toxicology · 29d
Cleared May 15, 2001
EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229
K011289 · DJG
Syva Co., Dade Behring, Inc.
Toxicology · 18d
Cleared May 10, 2001
MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229
K011164 · KXS
Syva Co., Dade Behring, Inc.
Toxicology · 24d
Cleared May 02, 2001
MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY
K011162 · DIO
Syva Co., Dade Behring, Inc.
Toxicology · 16d
Cleared Apr 26, 2001
EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229
K010960 · DIC
Syva Co., Dade Behring, Inc.
Toxicology · 27d
Cleared Apr 26, 2001
EMIT II PLUS METHADONE ASSAY, MODEL OSRE229
K010962 · DJR
Syva Co., Dade Behring, Inc.
Toxicology · 27d
Cleared Apr 20, 2001
RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS
K003809 · DKZ
Rapid Diagnostics, Inc.
Toxicology · 133d
Cleared Apr 20, 2001
EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229
K010934 · DIS
Syva Co., Dade Behring, Inc.
Toxicology · 23d
Cleared Apr 20, 2001
EMIT 2000 GENTAMICIN PLUS ASSAY
K010984 · LCD
Syva Co., Dade Behring, Inc.
Toxicology · 18d
Cleared Apr 17, 2001
LIVESURE COCAINE SCREEN TEST
K010967 · DIO
Pan Probe Biotech, Inc.
Toxicology · 15d
Cleared Apr 13, 2001
EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229
K010814 · KLT
Syva Co., Dade Behring, Inc.
Toxicology · 25d
Cleared Apr 13, 2001
VERDICT -II BAR
K010959 · DIS
Medtox Diagnostics, Inc.
Toxicology · 14d
Cleared Apr 13, 2001
LIVESURE MORPHINE SCREEN TEST
K011011 · DOE
Pan Probe Biotech, Inc.
Toxicology · 9d
Cleared Apr 11, 2001
AT WORK DRUG TEST, MODEL 9177T AWT
K010833 · DIO
Phamatech
Toxicology · 22d
Cleared Apr 11, 2001
AT WORK DRUG TEST, MODEL 9147T AWT
K010836 · LAF
Phamatech
Toxicology · 22d
Cleared Apr 05, 2001
VERDICT -II BAR/BZO
K010561 · DIS
Medtox Diagnostics, Inc.
Toxicology · 38d
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