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
1753–1776 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Dec 26, 1990
EMIT(R) II CANNABINOID 20 NG ASSAY
K904570 · LDJ
Syva Co.
Toxicology · 78d
Cleared Dec 26, 1990
EMIT(R) II CANNABINOID 50 NG ASSAY
K904571 · LDJ
Syva Co.
Toxicology · 78d
Cleared Dec 26, 1990
CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION
K905521 · LER
Microgenics Corp.
Toxicology · 19d
Cleared Dec 13, 1990
DSL CK-MB (DSL #3200)
K904721 · JHT
Diagnostic Systems Laboratories, Inc.
Toxicology · 56d
Cleared Dec 13, 1990
ABUSCREEN ONTRAK FOR THC
K904856 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 45d
Cleared Nov 28, 1990
HYCOR ACCUPINCH METHAMPHETAMINE TEST
K904115 · DKZ
Hycor Biomedical, Inc.
Toxicology · 83d
Cleared Nov 28, 1990
EMIT (R) II PHENCYCLIDINE ASSAY
K904765 · LCM
Syva Co.
Toxicology · 37d
Cleared Nov 28, 1990
ABUSCREEN ONLINE TM FOR COCAINE METABOLITE
K904995 · KLN
Roche Diagnostic Systems, Inc.
Toxicology · 21d
Cleared Nov 28, 1990
EZ-SCREEN:BARBITURATES
K905057 · DIS
Environmental Diagnostics, Inc.
Toxicology · 20d
Cleared Nov 20, 1990
LABELING SUBMITTAL, ADX TM CANNABINOIDS-GS
K904541 · LDJ
Abbott Laboratories
Toxicology · 47d
Cleared Nov 20, 1990
EMIT (R) II CALIBRATOR A LEVEL 1 (CUTOFF) 2 (HIGH)
K904764 · DKB
Syva Co.
Toxicology · 29d
Cleared Nov 09, 1990
DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD
K904301 · DKJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 51d
Cleared Nov 06, 1990
DUPONT SALICYLATE CALIBRATOR
K904307 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 48d
Cleared Nov 05, 1990
CEDIA(TM) PHENOBARBITAL ASSAY
K904413 · LAF
Microgenics Corp.
Toxicology · 40d
Cleared Nov 01, 1990
MICROZYME THC ENZYME IMMUNOASSAY TEST KIT
K904635 · LDJ
Immunotech Corp.
Toxicology · 21d
Cleared Oct 26, 1990
BLIND CONTROLS FOR DRUGS OF ABUSE TESTING
K903909 · DIF
Rapid Diagnostic Laboratories, Inc.
Toxicology · 65d
Cleared Oct 26, 1990
DUPONT DRUG CLIBRATOR-B
K904303 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 37d
Cleared Oct 26, 1990
DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD
K904304 · KLB
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 37d
Cleared Oct 15, 1990
DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD
K904305 · LCD
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 26d
Cleared Oct 15, 1990
DUPONT DRUG CALIBRATOR-A
K904306 · JJX
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 26d
Cleared Oct 12, 1990
STATLAB A-350 SALIVA ALCOHOL TEST
K903235 · DIC
Enzymatics C/O Burditt,Bowles,Radzius...
Toxicology · 81d
Cleared Oct 12, 1990
DUPONT DIMENSION(R) ETHYL ALCOHOL(ALC) METHOD
K904302 · DIC
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 23d
Cleared Oct 12, 1990
DUPONT ALCOHOL CALIBRATOR
K904308 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 23d
Cleared Oct 01, 1990
PREMIER-C. DIFFICILE TOXIN A
K903456 · LLH
Meridian Diagnostics, Inc.
Toxicology · 61d