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
1033–1056 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Aug 06, 1998
DBEST AMPHETAMINES TEST KIT
K981504 · DKZ
Ameritek, Inc.
Toxicology · 101d
Cleared Jul 29, 1998
PROFILE-II MODEL 600582
K982211 · DKE
Medtox Diagnostics, Inc.
Toxicology · 36d
Cleared Jul 22, 1998
UBI MAGIWEL MARIJUANA METABOLITES
K973154 · LDJ
United Biotech, Inc.
Toxicology · 334d
Cleared Jul 22, 1998
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
K981926 · DLJ
Emd Chemicals, Inc.
Toxicology · 50d
Cleared Jul 06, 1998
SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606
K981800 · HIH
Equal Diagnostics, Inc.
Toxicology · 46d
Cleared Jul 02, 1998
AC/AD LINEARITY VERIFIERS
K982217 · DIF
Sc Calibrators & Controls, LLC
Toxicology · 8d
Cleared Jun 29, 1998
GENIE CUP INTEGRATED SCREENING DEVICE
K980836 · LDJ
Applied Technology Ventures, LLC
Toxicology · 117d
Cleared Jun 29, 1998
SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40
K981872 · DKJ
Diagnostic Chemicals , Ltd.
Toxicology · 32d
Cleared Jun 29, 1998
OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3
K982024 · DIF
Medical Analysis Systems, Inc.
Toxicology · 20d
Cleared Jun 16, 1998
ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST
K981197 · DKZ
Tcpi, Inc.
Toxicology · 75d
Cleared Jun 12, 1998
ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP
K981771 · DJG
Princeton BioMeditech Corp.
Toxicology · 24d
Cleared Jun 10, 1998
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY...
K981590 · DIF
Bio-Rad
Toxicology · 37d
Cleared Jun 03, 1998
QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND...
K981687 · JXM
Phamatech
Toxicology · 21d
Cleared May 29, 1998
MICRO-STRIP FOR COCAINE METABOLITES
K981388 · DIO
Microdiagnostics, Inc.
Toxicology · 43d
Cleared May 28, 1998
ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT)
K981584 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared May 28, 1998
ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT)
K981585 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared May 26, 1998
CEDIA DAU EDDP ASSAY
K980746 · DJR
Boehringer Mannheim Corp.
Toxicology · 89d
Cleared May 26, 1998
QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST
K981292 · LCM
Syntron Bioresearch, Inc.
Toxicology · 47d
Cleared May 22, 1998
STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)
K981341 · DJG
OraSure Technologies, Inc.
Toxicology · 39d
Cleared May 18, 1998
MICRO-PLATE COTININE EIA
K974534 · MKU
OraSure Technologies, Inc.
Toxicology · 167d
Cleared May 14, 1998
MICRO-PLATE COTININE EIA
K974234 · MKU
OraSure Technologies, Inc.
Toxicology · 183d
Cleared May 12, 1998
ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30.
K981059 · LDP
Diagnostic Chemicals , Ltd.
Toxicology · 50d
Cleared May 08, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT
K981403 · DKB
Beckman Instruments, Inc.
Toxicology · 21d
Cleared May 07, 1998
QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST
K981019 · LCM
Syntron Bioresearch, Inc.
Toxicology · 50d