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
2041–2064 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Feb 11, 1988
REVISIED LABELING FOR ADX BENZODIAZEPINES
K880014 · JXM
Abbott Laboratories
Toxicology · 38d
Cleared Feb 03, 1988
ACA DU PONT URINE CANNABINOIDS (U THC) SCREEN METH
K875252 · LDJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 43d
Cleared Feb 02, 1988
STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III
K874757 · DIF
Baxter Healthcare Corp
Toxicology · 76d
Cleared Jan 21, 1988
CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY
K874824 · DII
Supelco, Inc.
Toxicology · 58d
Cleared Jan 11, 1988
RAICHEM(TM) ALCOHOL REAGENT
K874382 · DML
Reagents Applications, Inc.
Toxicology · 77d
Cleared Jan 11, 1988
REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS
K874626 · LCL
Syva Co.
Toxicology · 62d
Cleared Jan 05, 1988
REVISED LABELING FOR SYVA BARBITURATE ASSAYS
K874702 · DIS
Syva Co.
Toxicology · 50d
Cleared Jan 05, 1988
EMIT CONVENIENCE PACK: PHENYTOIN ASSAY
K874856 · DIP
Syva Co.
Toxicology · 41d
Cleared Dec 22, 1987
EMIT CONVENIENCE PACK: PHENOBARBITAL ASSAY
K874625 · DLZ
Syva Co.
Toxicology · 42d
Cleared Dec 18, 1987
EMIT CONVENIENCE PACK: GENTAMICIN ASSAY
K874703 · LCD
Syva Co.
Toxicology · 32d
Cleared Nov 23, 1987
TDXR MULTICONSTIT. CONTROLS FOR ABUSED DRUG ASSAYS
K873183 · DIF
Abbott Laboratories
Toxicology · 103d
Cleared Nov 23, 1987
REVISED LABELING FOR SYVA BENZODIAZEPINE ASSAYS
K874376 · JXM
Syva Co.
Toxicology · 28d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX BARBITURATES
K874483 · DIS
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX PHENCYCLIDINE
K874484 · LCL
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR OPIATES
K874485 · DJG
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX AMPHETAMINE/METHAMPHETA.
K874486 · DKZ
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX COCAINE METABOLITE
K874487 · DIO
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX CANNABINOIDS
K874488 · LDJ
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX BENZODIAZEPINES
K874489 · JXM
Abbott Laboratories
Toxicology · 24d
Cleared Nov 20, 1987
REVISED LABELING FOR CANNABINOIDS TEST KIT
K874269 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 31d
Cleared Nov 13, 1987
REVISED LABELING FOR ABUSCREEN EIA BARBITURATE
K874210 · DIS
Roche Diagnostic Systems, Inc.
Toxicology · 28d
Cleared Nov 13, 1987
ACA DU PONT URINE COCAINE METABOLITE (U COC)SCREEN
K874213 · DIO
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 28d
Cleared Nov 13, 1987
EMIT TOBRAMYCIN ASSAY
K874223 · KLB
Syva Co.
Toxicology · 28d
Cleared Nov 13, 1987
REVISED LABELING FOR BENZODIAZEPINE TEST KIT
K874265 · JXM
Roche Diagnostic Systems, Inc.
Toxicology · 24d