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
1393–1416 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Dec 02, 1994
BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC...
K934340 · LFI
Biosite Incorporated
Toxicology · 450d
Cleared Dec 02, 1994
COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR
K942847 · LAR
Roche Diagnostic Systems, Inc.
Toxicology · 169d
Cleared Dec 02, 1994
CX(TM) METHADONE(METD) REAGENT FOR SYNCHRON CX SYST
K944074 · DJR
Beckman Instruments, Inc.
Toxicology · 150d
Cleared Nov 30, 1994
CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS
K944087 · DIO
Beckman Instruments, Inc.
Toxicology · 148d
Cleared Nov 30, 1994
CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS
K944606 · DJG
Beckman-Diagnostic Systems Group
Toxicology · 72d
Cleared Nov 28, 1994
CALIBRATOR
K943012 · JIX
Prisma Systems
Toxicology · 157d
Cleared Nov 22, 1994
STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY
K934003 · DKA
Baxter Diagnostics, Inc.
Toxicology · 462d
Cleared Nov 21, 1994
CX(TM) BENZODIAZEPINE(BENZ) REAGENT FOR SYCHRON CX SYS
K944076 · JXM
Beckman Instruments, Inc.
Toxicology · 139d
Cleared Nov 21, 1994
CX(TM) CANNABINOID 100 NG(THC) REAGENT/SYNCHRON CX SYS
K944088 · LDJ
Beckman Instruments, Inc.
Toxicology · 139d
Cleared Nov 17, 1994
GENTAMICIN FPIA REAGENT SET AND CALIBRATORS
K943550 · LCQ
Sigma Diagnostics, Inc.
Toxicology · 119d
Cleared Nov 17, 1994
VERDICT OPIATES
K943712 · DJG
Editek, Inc.
Toxicology · 108d
Cleared Nov 15, 1994
EMIT 2000 DIGOXIN ASSAY
K943500 · KXT
Syva Co.
Toxicology · 133d
Cleared Nov 15, 1994
PROCHEQ 1 & 2
K944059 · JJY
Prisma Systems
Toxicology · 88d
Cleared Nov 15, 1994
DMA IRON PROCEDURE
K944462 · JIY
Data Medical Associates, Inc.
Toxicology · 64d
Cleared Nov 04, 1994
CANNABINOID EIA ASSAY
K943998 · LDJ
Diagnostic Reagents, Inc.
Toxicology · 136d
Cleared Nov 02, 1994
SOLOR CARE TECHNOLOGIES CORPORATION OPIATES
K941041 · DJG
Solar Technologies Corp.
Toxicology · 240d
Cleared Nov 02, 1994
TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL
K943422 · DIF
Utak Lab, Inc.
Toxicology · 110d
Cleared Oct 27, 1994
IMMULITE DIGITOXIN
K943235 · LFM
Diagnostic Products Corp.
Toxicology · 113d
Cleared Oct 27, 1994
PHENYTOIN FPIA REAGENT SET AND CALIBRATORS
K943313 · LGR
Sigma Diagnostics, Inc.
Toxicology · 108d
Cleared Oct 20, 1994
DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD
K943996 · CEP
Dupont Medical Products
Toxicology · 65d
Cleared Oct 06, 1994
THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED
K942551 · DIF
Medi-Tech, Inc.
Toxicology · 128d
Cleared Sep 16, 1994
MICROLINE SCREEN FOR AMPHETAMINE
K935052 · DKZ
Drug Screening Systems, Inc.
Toxicology · 331d
Cleared Sep 14, 1994
NIDA-5/RT, DRUG OF ABUSE CONTROLS
K942041 · DIF
Meditech
Toxicology · 139d
Cleared Sep 14, 1994
DOA-PLUS, DRUGS OF ABUSE CONTROLS
K942257 · DIF
Medical Diagnostic Technologies, Inc.
Toxicology · 128d