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
865–888 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Apr 14, 2000
URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A
K000460 · DKZ
Dade Behring, Inc.
Toxicology · 63d
Cleared Apr 14, 2000
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A
K000464 · DJG
Dade Behring, Inc.
Toxicology · 63d
Cleared Apr 14, 2000
URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
K000467 · DIO
Dade Behring, Inc.
Toxicology · 63d
Cleared Apr 14, 2000
SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT
K000494 · LDP
Beckman Coulter, Inc.
Toxicology · 59d
Cleared Apr 13, 2000
ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579
K994164 · LDJ
Roche Diagnostics Corp.
Toxicology · 126d
Cleared Apr 11, 2000
SCREENERS COCAINE TEST
K000350 · DIO
Drug Detection Devices, Ltd.
Toxicology · 68d
Cleared Apr 10, 2000
SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS
K000410 · DMT
Beckman Coulter, Inc.
Toxicology · 62d
Cleared Apr 10, 2000
REDI-SCREEN
K000979 · LAF
Redwood Biotech, Inc.
Toxicology · 14d
Cleared Apr 07, 2000
SCREENERS OPIATES TEST DRUGSCREEN DIP OPIATES TEST
K000273 · DJG
Drug Detection Devices, Ltd.
Toxicology · 70d
Cleared Apr 07, 2000
SCREENERS BENZODIAZEPINE (BZD) TEST, DRUG SCREEN DIP BENZODIAZEPINE (BZD) TEST
K000449 · JXM
Drug Detection Devices, Ltd.
Toxicology · 56d
Cleared Apr 07, 2000
ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595
K994165 · DIO
Roche Diagnostics Corp.
Toxicology · 120d
Cleared Apr 06, 2000
URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A
K000461 · LDJ
Dade Behring, Inc.
Toxicology · 55d
Cleared Apr 06, 2000
URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A
K000462 · LCM
Dade Behring, Inc.
Toxicology · 55d
Cleared Apr 05, 2000
URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A
K000466 · DJR
Dade Behring, Inc.
Toxicology · 54d
Cleared Apr 03, 2000
URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A
K000459 · DIS
Dade Behring, Inc.
Toxicology · 52d
Cleared Apr 03, 2000
RAPIDONE- BARBITURATE TEST
K992451 · DIS
American Bio Medica Corp.
Toxicology · 256d
Cleared Apr 03, 2000
RAPIDONE- BENZODIAZEPINE TEST
K992720 · JXM
American Bio Medica Corp.
Toxicology · 234d
Cleared Apr 03, 2000
STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I
K992918 · DKZ
OraSure Technologies, Inc.
Toxicology · 217d
Cleared Apr 03, 2000
STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I
K993208 · LAF
OraSure Technologies, Inc.
Toxicology · 192d
Cleared Mar 07, 2000
QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI...
K000447 · LAF
Phamatech
Toxicology · 26d
Cleared Mar 03, 2000
IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 &...
K000005 · LEG
Diagnostic Products Corp.
Toxicology · 60d
Cleared Mar 03, 2000
IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5
K000012 · DLZ
Diagnostic Products Corp.
Toxicology · 60d
Cleared Feb 28, 2000
IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2,...
K000006 · DIP
Diagnostic Products Corp.
Toxicology · 56d
Cleared Feb 28, 2000
IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 &...
K000007 · KLT
Diagnostic Products Corp.
Toxicology · 56d