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
1297–1320 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Aug 02, 1995
AXSYM COCAINE METABOLITE
K951289 · DIO
Abbott Laboratories
Toxicology · 134d
Cleared Aug 02, 1995
ACS GENTAMICIN
K953020 · LCD
Ciba Corning Diagnostics Corp.
Toxicology · 34d
Cleared Jul 19, 1995
IMX DIGOXIN
K952079 · KXT
Abbott Laboratories
Toxicology · 77d
Cleared Jul 14, 1995
SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE
K926253 · JKA
Sudormed, Inc.
Toxicology · 942d
Cleared Jul 14, 1995
STC COCAINE METABOLITE EIA
K934775 · DIO
Solarcare, Inc.
Toxicology · 647d
Cleared Jul 14, 1995
SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN...
K935564 · JKA
Sudormed, Inc.
Toxicology · 603d
Cleared Jul 14, 1995
OPIATES MICRO-PLATE ASSAY
K935565 · DJG
Solarcare Technologies Corp,Inc.
Toxicology · 603d
Cleared Jul 14, 1995
AMPHETAMINES MICRO-PLATE EIA
K935573 · DKZ
Solarcare Technologies Corp,Inc.
Toxicology · 603d
Cleared Jul 14, 1995
SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF AMPHETAMINES IN...
K935588 · JKA
Sudormed, Inc.
Toxicology · 604d
Cleared Jul 03, 1995
OPUS PROCAINAMIDE
K951434 · LAR
Behring Diagnostics, Inc.
Toxicology · 97d
Cleared Jun 23, 1995
DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL
K952412 · DIF
Dupont Medical Products
Toxicology · 31d
Cleared Jun 21, 1995
MSI PROCEDURE KIT
K944226 · DOX
Msi, Inc.
Toxicology · 295d
Cleared Jun 20, 1995
CEDIA DAU BENZODIAZEPINE ASSAY
K951710 · JXM
Microgenics Corp.
Toxicology · 67d
Cleared Jun 19, 1995
CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY
K951059 · LEH
Ciba Corning Diagnostics Corp.
Toxicology · 104d
Cleared Jun 09, 1995
IL TEST DIGOXIN, PN 181761-00
K951391 · KXT
Instrumentation Laboratory CO
Toxicology · 74d
Cleared Jun 01, 1995
ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS...
K951319 · DOE
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Jun 01, 1995
DUPONT ACA DIGOXIN (DGN A) METHOD
K951441 · KXT
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 64d
Cleared Jun 01, 1995
IMMUNOASSAY DRUGS OF ABUSE CONTROLS
K952056 · DIF
Medi-Tech, Inc.
Toxicology · 30d
Cleared May 18, 1995
AXSYM BARBITURATES II U
K951253 · DIS
Abbott Laboratories
Toxicology · 58d
Cleared May 18, 1995
AXSYM OPIATES
K951287 · DJG
Abbott Laboratories
Toxicology · 58d
Cleared May 16, 1995
ABBOTT AXSYM II SYSTEM
K950915 · JJE
Abbott Laboratories
Toxicology · 76d
Cleared May 16, 1995
AXSYM BENZODIAZEPINES
K951286 · JXM
Abbott Laboratories
Toxicology · 56d
Cleared May 16, 1995
AXSYM CANNABINOIDS
K951288 · JXM
Abbott Laboratories
Toxicology · 56d
Cleared May 08, 1995
CEDIA DAU AMPHETAMINES ASSAY
K951154 · DKZ
Microgenics Corp.
Toxicology · 55d