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
1345–1368 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Mar 15, 1995
DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD
K950180 · DLI
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 57d
Cleared Mar 10, 1995
DUPONT ACA VANCOMYCIN (VANC) METHOD
K945125 · LEH
The DU Pont Co.
Toxicology · 142d
Cleared Mar 09, 1995
COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS
K945523 · LCQ
Roche Diagnostic Systems, Inc.
Toxicology · 119d
Cleared Feb 22, 1995
EMIT IIC BARBITURATE ASSAY
K935116 · DIS
Syva Co.
Toxicology · 483d
Cleared Feb 22, 1995
EMIT IIC PHENCYCLIDINE ASSAY
K935191 · LCM
Syva Co.
Toxicology · 484d
Cleared Feb 22, 1995
EMIT IIC COCAINE METABOLITE ASSAY
K935323 · DIO
Syva Co.
Toxicology · 475d
Cleared Feb 22, 1995
EMIT(R) IIC AMPHETAMINE ASSAY
K935352 · DKZ
Syva Co.
Toxicology · 474d
Cleared Feb 22, 1995
EMIT IIC CANNABINOID ASSAY
K940158 · LDJ
Syva Co.
Toxicology · 406d
Cleared Feb 22, 1995
ABUSIGN DOA4
K943439 · DKZ
Princeton BioMeditech Corp.
Toxicology · 219d
Cleared Feb 22, 1995
ABUSIGN(TM) THC, DOA-THC, ACCUSIGN(TM) THC, DOA-THC, DIOSIGN(TM) THC, DOA-THC
K945550 · LDJ
Princeton BioMeditech Corp.
Toxicology · 100d
Cleared Feb 22, 1995
ABUSIGN(TM) COC, DOA-COC, ACCUSIGN(TM) COC, DOA-COC, DIOSIGN(TM) COC, DOA-COC
K945609 · DIO
Princeton BioMeditech Corp.
Toxicology · 99d
Cleared Feb 22, 1995
DIGOXIN FLEX(TM) REAGENT CARTRIDGE
K946153 · KXT
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 68d
Cleared Feb 22, 1995
DRUGS OF ABUSE CONTROLS
K950138 · DIF
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 40d
Cleared Feb 22, 1995
DRUGS OF ABUSE CALIBRATOR
K950139 · DKB
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 40d
Cleared Feb 10, 1995
ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPI
K945608 · DJG
Princeton BioMeditech Corp.
Toxicology · 87d
Cleared Feb 10, 1995
PHENOBARBITAL ENZYME IMMUNOASSAY
K946210 · DLZ
Diagnostic Reagents, Inc.
Toxicology · 51d
Cleared Feb 08, 1995
STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA
K944372 · JXN
Solarcare, Inc.
Toxicology · 154d
Cleared Feb 08, 1995
LIQUISPEX(TM) URINE ETHANOL CONTROL
K946144 · JJX
Clinical Controls, Inc.
Toxicology · 54d
Cleared Feb 07, 1995
ROCHE-TDM ONLEIN(TM) CONTROLS
K946119 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 54d
Cleared Feb 03, 1995
PHENYTION EIA TEST
K945725 · DIP
Diagnostic Reagents, Inc.
Toxicology · 73d
Cleared Feb 01, 1995
BLOOD KIT, SEXUAL ASSAULT KIT
K945245 · JKA
Lynn Peavey Co.
Toxicology · 97d
Cleared Jan 30, 1995
VISUALINE II MORPHINE/OPIATES/HEROIN
K943248 · DJG
Sun Biomedical Laboratories, Inc.
Toxicology · 208d
Cleared Jan 27, 1995
CHOLESTEROL QVET
K943027 · CHH
Prisma Systems
Toxicology · 214d
Cleared Jan 25, 1995
IL TEST CARBAMAZEPINE, PN 181754-00
K942687 · KLT
Instrumentation Laboratory CO
Toxicology · 232d