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
1081–1104 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Jan 28, 1998
STC METHAMPHETAMINE MICRO-PLATE EIA
K972989 · DKZ
OraSure Technologies, Inc.
Toxicology · 169d
Cleared Jan 22, 1998
REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE
K974699 · DKB
Consolidated Technologies, Inc.
Toxicology · 37d
Cleared Jan 07, 1998
OVULON MONITOR
K973860 · NGE
Conception Technology, Inc.
Toxicology · 90d
Cleared Jan 02, 1998
STC COCAINE METABOLITE MICRO-PLATE EIA
K973651 · DIO
OraSure Technologies, Inc.
Toxicology · 99d
Cleared Dec 24, 1997
MICRO-STRIP FOR OPIATE METABOLITES
K973761 · DJG
Microdiagnostics, Inc.
Toxicology · 83d
Cleared Dec 16, 1997
ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM
K974322 · DOP
Europa Scientific, Ltd.
Toxicology · 29d
Cleared Dec 11, 1997
ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN...
K974181 · JXM
Princeton BioMeditech Corp.
Toxicology · 35d
Cleared Dec 03, 1997
TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER...
K973784 · DKZ
Biosite Incorporated
Toxicology · 61d
Cleared Nov 12, 1997
ACE VALPROIC ACID REAGENT, AED CALIBRATORS
K973581 · LEG
Schiapparelli Biosystems, Inc.
Toxicology · 51d
Cleared Nov 12, 1997
ACE PRIMIDONE REAGENT, AED CALIBRATORS
K973582 · DJD
Schiapparelli Biosystems, Inc.
Toxicology · 51d
Cleared Nov 12, 1997
ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS
K973583 · KLS
Schiapparelli Biosystems, Inc.
Toxicology · 51d
Cleared Nov 06, 1997
FINGERPRINT DRUG SCREENING DEVICE
K973726 · DKZ
Applied Technology Ventures, LLC
Toxicology · 37d
Cleared Nov 04, 1997
ACE PHENYTOIN REAGENT, AED CALIBRATORS
K973414 · DIP
Schiapparelli Biosystems, Inc.
Toxicology · 56d
Cleared Oct 28, 1997
UBI MAGIWEL AMPHETAMINE METABOLITES
K973153 · DJG
United Biotech, Inc.
Toxicology · 67d
Cleared Oct 28, 1997
UBI MAGIWEL OPIATE METABOLITES
K973155 · DJG
United Biotech, Inc.
Toxicology · 67d
Cleared Oct 28, 1997
UBI MAGIWEL COCAINE METABOLITES
K973156 · DJG
United Biotech, Inc.
Toxicology · 67d
Cleared Oct 27, 1997
OPUS HLH CONTROLS
K973832 · JJX
Behring Diagnostics, Inc.
Toxicology · 20d
Cleared Oct 21, 1997
AUTO-LYTE COTININE EIA
K972481 · MKU
OraSure Technologies, Inc.
Toxicology · 111d
Cleared Oct 10, 1997
ACCUMETER THEOPHYLLINE TEST
K972495 · KLS
Chemtrak, Inc.
Toxicology · 99d
Cleared Oct 10, 1997
ELECSYS DIGOXIN
K973112 · KXT
Boehringer Mannheim Corp.
Toxicology · 51d
Cleared Oct 09, 1997
ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK...
K973075 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 52d
Cleared Oct 06, 1997
2487 DUAL WAVELENGTH ABSORBANCE DETECTOR
K973074 · KZR
Waters Corporation
Toxicology · 49d
Cleared Oct 02, 1997
ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST
K973047 · DIS
Drial Consultants, Inc.
Toxicology · 48d
Cleared Oct 01, 1997
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
K973054 · DNN
Emd Chemicals, Inc.
Toxicology · 47d