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
2137–2160 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Apr 22, 1987
EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95
K871330 · DLJ
Em Diagnostic Systems, Inc.
Toxicology · 19d
Cleared Apr 14, 1987
DART THEOPHYLLINE REAGENT SYSTEM
K870736 · KLS
Coulter Electronics, Inc.
Toxicology · 48d
Cleared Apr 14, 1987
EMIT CARBAMAZEPINE ASSAY
K871306 · KLT
Syva Co.
Toxicology · 13d
Cleared Apr 01, 1987
DIGOXIN (FPIA) CALIBRATOR KIT
K870389 · DLJ
Windsor Laboratories, Inc.
Toxicology · 61d
Cleared Apr 01, 1987
PHENOBARBITAL (FPIA) CALIBRATOR KIT
K870390 · DLJ
Windsor Laboratories, Inc.
Toxicology · 61d
Cleared Apr 01, 1987
TDCONTROL LIQUID MULTI-ANALYTE THERAPEUTIC DRUG
K870586 · DIF
Medical Analysis Systems, Inc.
Toxicology · 49d
Cleared Apr 01, 1987
DIGOXIN FPIA REAGENT SET
K870951 · KXT
Sigma Diagnostics, Inc.
Toxicology · 22d
Cleared Mar 31, 1987
QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE
K864993 · DIS
General Diagnostics
Toxicology · 99d
Cleared Mar 31, 1987
THEOPHYLLINE FPIA REAGENT SET
K870952 · KLS
Sigma Diagnostics, Inc.
Toxicology · 21d
Cleared Mar 31, 1987
PHENYTOIN FPIA REAGENT SET
K870953 · DIP
Sigma Diagnostics, Inc.
Toxicology · 21d
Cleared Mar 24, 1987
ABUSCREEN RADIOIMMUNOASSAY FOR BENZODIAZEPINES
K870994 · JXM
Roche Diagnostic Systems, Inc.
Toxicology · 13d
Cleared Mar 20, 1987
EMIT NORTRIPTYLINE ASSAY
K870823 · LFG
Syva Co.
Toxicology · 17d
Cleared Mar 19, 1987
THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT
K863913 · DOE
Diagnostic Products Corp.
Toxicology · 162d
Cleared Mar 19, 1987
COAT-A-COUNT COCAINE METABOLITE TKCN1 & TKCN5
K870740 · KLN
Diagnostic Products Corp.
Toxicology · 22d
Cleared Mar 19, 1987
COAT-A-COUNT PCP KIT NUMBER TKPC1
K870875 · LCN
Diagnostic Products Corp.
Toxicology · 16d
Cleared Mar 19, 1987
COAT-A-COUNT METHAQUALONE TKMQ1
K870935 · KXS
Diagnostic Products Corp.
Toxicology · 10d
Cleared Mar 19, 1987
COAT-A-COUNT BARBITURATES TKBA1 AND TKBA5
K870936 · DIS
Diagnostic Products Corp.
Toxicology · 10d
Cleared Mar 19, 1987
COAT-A-COUNT METHADONE TKMD1
K870937 · DJR
Diagnostic Products Corp.
Toxicology · 10d
Cleared Mar 16, 1987
COCAINE METABOLITE ROCHE(R) EIA
K863843 · DIO
Roche Diagnostic Systems, Inc.
Toxicology · 166d
Cleared Mar 16, 1987
MORPHINE ROCHE (R) EIA TEST
K864168 · DOE
Roche Diagnostic Systems, Inc.
Toxicology · 143d
Cleared Mar 16, 1987
ABUSCREEN (R) EIA CANNABINOIDS
K870377 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 46d
Cleared Mar 16, 1987
ABUSCREEN (R) EIA BARBITURATE
K870378 · DIS
Roche Diagnostic Systems, Inc.
Toxicology · 46d
Cleared Mar 12, 1987
BENZODIAZEPINE ENZYME IMMUNOASSAY KIT
K863877 · JXM
General Diagnostics
Toxicology · 157d
Cleared Feb 18, 1987
MONITORX LASERX THEOPHYLLINE REAGENT SET
K870277 · LGS
American Monitor Corp.
Toxicology · 22d