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
1993–2016 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Jul 29, 1988
ABUSCREEN(R) ONTRAK(TM) FOR THC
K881814 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 92d
Cleared Jul 29, 1988
ABUSCREEN(R) ONTRAK(TM) FOR COCAINE
K881815 · DIO
Roche Diagnostic Systems, Inc.
Toxicology · 92d
Cleared Jul 29, 1988
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES
K881817 · DJP
Roche Diagnostic Systems, Inc.
Toxicology · 92d
Cleared Jul 28, 1988
ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES
K881816 · DKN
Roche Diagnostic Systems, Inc.
Toxicology · 91d
Cleared Jul 12, 1988
EMIT HVA COCAINE METABOLITE ASSAY
K881942 · DIO
Syva Co.
Toxicology · 64d
Cleared Jul 12, 1988
EMIT HVA PHENCYCLIDINE ASSAY
K882179 · LCL
Syva Co.
Toxicology · 49d
Cleared Jul 08, 1988
LIQUI-SERA SERUM ALCOHOL CONTROLS
K881430 · JJX
Biodiagnostic Intl
Toxicology · 94d
Cleared Jul 08, 1988
EMIT HVA CALIBRATOR KIT
K881943 · DKB
Syva Co.
Toxicology · 60d
Cleared Jul 08, 1988
EMIT HVA CONTROL KIT
K881944 · DIF
Syva Co.
Toxicology · 60d
Cleared Jul 05, 1988
MODIFIED LABELING FOR TOXI-LAB THC SCREEN
K875182 · DKE
Marion Laboratories, Inc.
Toxicology · 201d
Cleared Jul 01, 1988
EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAY
K882294 · KLB
Syva Co.
Toxicology · 29d
Cleared Jun 24, 1988
MODIFICATION TO KDI QUIK TEST MARIJUANA SCREEN
K875219 · LDJ
Keystone Diagnostics, Inc.
Toxicology · 185d
Cleared Jun 24, 1988
MICROMEDIC MORPHINE RIA KIT
K881102 · DOE
Icn Micromedic Systems
Toxicology · 101d
Cleared Jun 22, 1988
HIGH PERFORMANCE CALIBRATORS
K875216 · DKB
Rapid Diagnostic Laboratories, Inc.
Toxicology · 183d
Cleared Jun 20, 1988
LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL
K880145 · DIF
Bio-Rad
Toxicology · 159d
Cleared Jun 20, 1988
EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641
K881116 · KLR
Diagnostic Systems
Toxicology · 97d
Cleared Jun 20, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL
K881989 · DIF
Bio-Rad
Toxicology · 39d
Cleared Jun 20, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW
K881990 · DIF
Bio-Rad
Toxicology · 39d
Cleared Jun 20, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE
K881991 · DIF
Bio-Rad
Toxicology · 39d
Cleared Jun 01, 1988
EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647
K881607 · DLF
Em Diagnostic Systems, Inc.
Toxicology · 50d
Cleared May 31, 1988
PAR(TM) BRAND DRUG OF ABUSE CONTROLS
K880152 · DIF
Medical Analysis Systems, Inc.
Toxicology · 139d
Cleared May 31, 1988
INCOS 50 MASS SPECTROMETER
K880418 · DOP
Finnigan Corp.
Toxicology · 120d
Cleared May 31, 1988
THERAPEUTIC DRUG STANDARD
K880705 · DKB
Verichem Laboratories, Inc.
Toxicology · 99d
Cleared May 31, 1988
AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT
K880823 · KXT
Amersham Corp.
Toxicology · 91d