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
1369–1392 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Jan 25, 1995
IL TEST GENTAMICIN CALIBRATORS
K943982 · LCD
Instrumentation Laboratory CO
Toxicology · 232d
Cleared Jan 25, 1995
ABUSCREEN ONTRAK POSITIVE CONTROL
K943999 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 187d
Cleared Jan 25, 1995
MICROLINE SCREEN FOR BENZODIAZEPINE
K945829 · JXM
Drug Screening Systems, Inc.
Toxicology · 57d
Cleared Jan 25, 1995
ABUSCREEN ONLINE(R) CALIBRATORS
K946000 · DKJ
Roche Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Jan 18, 1995
IL TEST THEOPHYLLINE
K943979 · KLS
Instrumentation Laboratory CO
Toxicology · 225d
Cleared Jan 18, 1995
IL TEST PHENOBARBITAL CALIBRATORS
K943981 · DLZ
Instrumentation Laboratory CO
Toxicology · 225d
Cleared Jan 17, 1995
THEOPHYLLINE CALIBRATORS
K945338 · DLJ
Diagnostic Reagents, Inc.
Toxicology · 77d
Cleared Jan 17, 1995
CEDIA DAU OPIATE ASSAY
K945343 · DJG
Microgenics Corp.
Toxicology · 77d
Cleared Jan 17, 1995
CEDIA DAU COCAINE ASSAY
K945345 · DIO
Microgenics Corp.
Toxicology · 77d
Cleared Jan 17, 1995
CEDIA(R) DAU PCP ASSAY
K946059 · LCM
Microgenics Corp.
Toxicology · 36d
Cleared Jan 04, 1995
PHENOBARBITAL CALIBRATORS
K945316 · DLJ
Diagnostic Reagents, Inc.
Toxicology · 64d
Cleared Dec 29, 1994
AUTO-LYTE METHADONE DIA
K944056 · DJR
Solarcare Technologies Corp,Inc.
Toxicology · 132d
Cleared Dec 29, 1994
CX(TM) BARBITURATES(BARB) REAGENT FOR SYNCHRON CX SYST
K944075 · DIS
Beckman Instruments, Inc.
Toxicology · 177d
Cleared Dec 29, 1994
CX(TM) CANNABINOID 50NG(THC5) REAGENT/SYNCHRON CX SYS
K944086 · LDJ
Beckman Instruments, Inc.
Toxicology · 177d
Cleared Dec 28, 1994
PHENOBARBITAL FLEX REAGENT CARTRIDGE
K944932 · DLZ
Dupont Medical Products
Toxicology · 83d
Cleared Dec 28, 1994
CEDIA DAU BARBITURATE ASSAY
K945344 · DIS
Microgenics Corp.
Toxicology · 57d
Cleared Dec 19, 1994
ABBOTT IMX 2 ANALYZER
K944731 · JJI
Abbott Laboratories
Toxicology · 98d
Cleared Dec 13, 1994
DOA - IMMUNOASSAY CUT-OFF CALIBRATOR
K945289 · DKB
Medi-Tech, Inc.
Toxicology · 43d
Cleared Dec 09, 1994
AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT
K944490 · CGI
Wallac OY
Toxicology · 87d
Cleared Dec 09, 1994
ABUSCREEN ONLINE CONTROLS
K945194 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 46d
Cleared Dec 09, 1994
ABUSCREEN ONLINE PROPOXPHENE
K945195 · JXN
Roche Diagnostic Systems, Inc.
Toxicology · 46d
Cleared Dec 07, 1994
CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS
K944604 · DKZ
Beckman-Diagnostic Systems Group
Toxicology · 79d
Cleared Dec 07, 1994
CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM
K944605 · LCM
Beckman-Diagnostic Systems Group
Toxicology · 79d
Cleared Dec 07, 1994
PHENYTOIN CALIBRATORS
K945337 · DLJ
Diagnostic Reagents, Inc.
Toxicology · 36d