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
1249–1272 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Feb 15, 1996
TRIAGE PANEL FOR DRUGS OF ABUSE/TRICYCLIC ANTIDEPRESSANTS
K955935 · DKZ
Biosite Incorporated
Toxicology · 64d
Cleared Feb 09, 1996
INNOFLUOR GENTAMICIN ASSAY SYSTEM
K955569 · LCQ
Oxis Intl., Inc.
Toxicology · 65d
Cleared Feb 09, 1996
INNOFLUOR AMIKACIN ASSAY SYSTEM
K955570 · KLQ
Oxis Intl., Inc.
Toxicology · 65d
Cleared Feb 09, 1996
SYNCHRON SYSTEMS PROPOXYPHENE REAGENT
K955675 · JXN
Beckman Instruments, Inc.
Toxicology · 56d
Cleared Feb 09, 1996
CEDIA DAU LSD CALBIRATORS
K955813 · DLJ
Microgenics Corp.
Toxicology · 45d
Cleared Feb 09, 1996
CEDIA DAU LSD ASSAY
K955814 · DLB
Microgenics Corp.
Toxicology · 45d
Cleared Feb 05, 1996
LYPHOCHEK BENZO/TCA CONTROL-SET B
K955153 · DIF
Bio-Rad
Toxicology · 84d
Cleared Jan 30, 1996
BENZODIAZEPINES BY REMEDI HS
K955116 · LAA
Bio-Rad
Toxicology · 82d
Cleared Jan 24, 1996
CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05
K955498 · DIH
Diagnostic Chemicals , Ltd.
Toxicology · 54d
Cleared Jan 24, 1996
INNOFLUOR PHENYTOIN ASSAY SYSTEM
K955562 · LGR
Oxis Intl., Inc.
Toxicology · 49d
Cleared Jan 24, 1996
INNOFLUOR THEOPHYLLINE ASSAY SYSTEM
K955567 · LGS
Oxis Intl., Inc.
Toxicology · 49d
Cleared Dec 29, 1995
AXSYM DIGITOXIN
K954420 · LFM
Abbott Laboratories
Toxicology · 99d
Cleared Dec 18, 1995
EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN
K954933 · LDP
Johnson & Johnson Clinical...
Toxicology · 52d
Cleared Dec 13, 1995
ONTRAJ TESTCUP COLLECTION/URINALYSIS PANEL
K954799 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 56d
Cleared Dec 13, 1995
CARBAMAZEPINE EIA TEST
K955100 · KLT
Diagnostic Reagents, Inc.
Toxicology · 35d
Cleared Dec 11, 1995
ACS PHENOBARBITAL
K953021 · DIS
Ciba Corning Diagnostics Corp.
Toxicology · 165d
Cleared Nov 29, 1995
STC DIAGNOSTICS LSD MICRO-PLATE EIA
K954073 · DLB
Solarcare Technologies Corp,Inc.
Toxicology · 91d
Cleared Nov 27, 1995
CEDIA DAU BENZODIAZEPINE ASSAY(MODIFICATION)
K954626 · JXM
Microgenics Corp.
Toxicology · 55d
Cleared Nov 22, 1995
AXSYM TRICYCLIC ANTIDEPRESSANTS
K953761 · LFH
Abbott Laboratories
Toxicology · 103d
Cleared Nov 20, 1995
OPUS TDM CONTROLS
K954291 · DIF
Behring Diagnostics, Inc.
Toxicology · 67d
Cleared Nov 17, 1995
CEDIA DAU METHADONE ASSAY
K954227 · DJR
Microgenics Corp.
Toxicology · 67d
Cleared Nov 13, 1995
AXSYM METHADONE
K953499 · DJR
Abbott Laboratories
Toxicology · 110d
Cleared Nov 13, 1995
IMMULITE THEOPHYLLINE
K954569 · KLS
Diagnostic Products Corp.
Toxicology · 42d
Cleared Nov 06, 1995
AVOXIMETER 4000
K951485 · JKS
A-Vox Systems, Inc.
Toxicology · 221d