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
1585–1608 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Sep 11, 1992
WATERS(TM) LC MODULE I FOR CLINICAL USE
K922388 · LDM
Millipore Corp.
Toxicology · 114d
Cleared Aug 27, 1992
ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE
K922991 · LGS
Abbott Laboratories
Toxicology · 66d
Cleared Aug 24, 1992
DIGOXIN COATED TUBE RIA
K922353 · LCS
Monobind
Toxicology · 97d
Cleared Aug 24, 1992
EMIT 2000 PROCAINAMIDE CALIBRATORS
K922914 · LAR
Syva Co.
Toxicology · 68d
Cleared Aug 24, 1992
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT
K922915 · LAN
Syva Co.
Toxicology · 68d
Cleared Aug 24, 1992
AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY
K923314 · JXO
Serex, Inc.
Toxicology · 48d
Cleared Aug 20, 1992
STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIA
K921140 · JXO
Solarcare Technologies Corp,Inc.
Toxicology · 163d
Cleared Aug 20, 1992
STC DIAGNOSTICS AUTO-LYTE OPIATE EIA
K921328 · DJG
Solarcare Technologies Corp,Inc.
Toxicology · 155d
Cleared Aug 05, 1992
BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL
K920525 · DIS
Biotrack, Inc.
Toxicology · 183d
Cleared Aug 04, 1992
ROCHE ABUSCREEN ONLINNE CALIBRATORS
K923340 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 40d
Cleared Jul 23, 1992
BIOTRACK PHENYTOIN TEST CARTRIDGE
K915755 · DIP
Biotrack, Inc.
Toxicology · 213d
Cleared Jul 23, 1992
BIOTRACK CARBAMAZEPINE TEST CARTRIDGE
K915756 · KLT
Biotrack, Inc.
Toxicology · 213d
Cleared Jul 16, 1992
SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR)
K921939 · LAS
Heraeus Kulzer, Inc.
Toxicology · 83d
Cleared Jul 08, 1992
MICROLINE SCREEN FOR PHENCYCLIDINE
K921651 · LCM
Drug Screening Systems, Inc.
Toxicology · 93d
Cleared Jun 15, 1992
AUTOMATES COMA COCAINE METABOLITE ASSAY
K921834 · DIO
Serex, Inc.
Toxicology · 60d
Cleared Jun 10, 1992
CHEM CHEX THEOPHYLLINE CONTROL
K920223 · LAW
Streck Laboratories, Inc.
Toxicology · 145d
Cleared May 26, 1992
ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED
K921998 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 33d
Cleared May 13, 1992
SYVA EMIT II METHAQUALONE ASSAY
K921013 · KXS
Syva Co.
Toxicology · 71d
Cleared May 04, 1992
AMPHETAMINES EIA TEST
K921554 · DKZ
Diagnostic Reagents, Inc.
Toxicology · 33d
Cleared Apr 24, 1992
IL TEST BARBITURATE, 35289
K920417 · DIS
Instrumentation Laboratory CO
Toxicology · 84d
Cleared Apr 24, 1992
IL TEST METHADONE
K920858 · DJR
Instrumentation Laboratory CO
Toxicology · 59d
Cleared Apr 17, 1992
TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION)
K920314 · DIS
Syntex Corp.
Toxicology · 85d
Cleared Apr 17, 1992
CANNABINOID URINE CONTROLS
K921141 · LAS
Diagnostic Reagents, Inc.
Toxicology · 38d
Cleared Mar 19, 1992
ACCUSCREEN ASSAY
K920018 · DKZ
Jk Research
Toxicology · 77d