FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Toxicology ×
3,028 results
1393–1416 of 3,028
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
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
Cleared Sep 09, 1994
THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED
K942552 · DIF
Medi-Tech, Inc.
Toxicology · 101d