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
1513–1536 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Oct 01, 1993
IL TEST CARBAMAZEPHINE
K933684 · KLT
Instrumentation Laboratory CO
Toxicology · 64d
Cleared Sep 24, 1993
ROCHE ABUSCREEN ONLINE FOR METHADONE
K930928 · DJR
Roche Diagnostic Systems, Inc.
Toxicology · 213d
Cleared Sep 24, 1993
TOXI*LAB LTD OPIATE SYSTEM
K932209 · LAI
Toxi-Lab, Inc.
Toxicology · 141d
Cleared Sep 24, 1993
PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS
K932685 · KLS
Baxter Diagnostics, Inc.
Toxicology · 113d
Cleared Sep 21, 1993
CEDIA VALPORIC ACID ASSAY
K930734 · LEG
Microgenics Corp.
Toxicology · 222d
Cleared Sep 15, 1993
ABUSCREEN ONLINE(R) FOR AMPHETAMINES, MODIFIED
K933052 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 112d
Cleared Sep 10, 1993
REFERENCE MATERIAL FOR PHENCYCLIDINE IN HUMAN URINE
K933557 · LAS
Consolidated Technologies, Inc.
Toxicology · 51d
Cleared Aug 30, 1993
ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF
K933053 · DIO
Roche Diagnostic Systems, Inc.
Toxicology · 96d
Cleared Aug 27, 1993
TRI-TECH INC. CUSTOM BLOOD ALCOHOL
K922342 · JKA
Tri-Tech, Inc.
Toxicology · 465d
Cleared Aug 26, 1993
ABUSCREEN ONLINE LOW-CUTOFF CONTROLS
K932549 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 92d
Cleared Aug 23, 1993
METHADONE METABOLITE EIA ASSAY
K931780 · DJR
Diagnostic Reagents, Inc.
Toxicology · 136d
Cleared Aug 16, 1993
VIDAS THEOPHYLLINE(THEO)
K933258 · KLS
Biomerieux Vitek, Inc.
Toxicology · 41d
Cleared Aug 09, 1993
ABUSCREEN ONLINE BENZODIAZEPINES 300 CALIBRATOR
K933279 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 34d
Cleared Aug 05, 1993
BENZODIAZEPINE ENZYME IMMUNOASSAY
K930529 · JXM
Diagnostic Reagents, Inc.
Toxicology · 184d
Cleared Aug 05, 1993
DIGOXIN TEST SYSTEM, KXT TX
K931123 · KXT
Syva Co.
Toxicology · 154d
Cleared Aug 03, 1993
ABUSCREEN ONLINE(R) CALIBRATORS
K931124 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 152d
Cleared Aug 03, 1993
ABUSCREEN ONLINE CONTROL
K931125 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 152d
Cleared Jul 28, 1993
URINE CALIBRATOR AND CONTROL
K931506 · DLJ
Diagnostic Reagents, Inc.
Toxicology · 125d
Cleared Jul 26, 1993
CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL
K932662 · LAS
More Diagnostics
Toxicology · 54d
Cleared Jul 22, 1993
ROCHE ABUSCREEN TRI-LEVEL REFERENCE CONTROLS
K932753 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 55d
Cleared Jul 22, 1993
ABUSCREEN CALIBRATION STANDARD
K932754 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 55d
Cleared Jul 20, 1993
SOLARCARE TECHNOLOGIES CORP. MICROPLATE AMP. ASSAY
K931498 · DKZ
Solarcare Technologies Corp,Inc.
Toxicology · 117d
Cleared Jul 19, 1993
STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY
K931516 · DIC
Solarcare Technologies Corp,Inc.
Toxicology · 115d
Cleared Jul 14, 1993
TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II
K932615 · LAO
Abbott Laboratories
Toxicology · 43d