FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

84 results for "LSI International, Inc."
73–84 of 84
Search insights Median review: 56d Cleared: 100% Top manufacturer: Healgen Scientific, LLC Lead specialty: Toxicology
Cleared Jul 16, 2015
EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine...
K151557 · DNK
Nantong Egens Biotech Co., Ltd.
Toxicology · 36d
Cleared Jul 01, 2015
Wondfo CR3 Keyless Split Sample Cup
K151478 · DJG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 29d
Cleared May 13, 2015
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
K150356 · JXM
Healgen Scientific, LLC
Chemistry · 90d
Cleared Apr 24, 2015
Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen...
K150791 · DIS
Healgen Scientific, LLC
Toxicology · 30d
Cleared Apr 07, 2015
CR3 Keyless Split Sample Cup Morphine - Methamphetamine
K150602 · DNK
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 28d
Cleared Mar 04, 2015
Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen...
K150096 · LAF
Healgen Scientific, LLC
Toxicology · 43d
Cleared Feb 25, 2015
CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids
K150179 · DJG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 29d
Cleared Jan 27, 2015
Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone...
K143187 · DJG
Healgen Scientific, LLC
Chemistry · 83d
Cleared Jan 13, 2015
CR3 Keyless Split Sample Cup Secobarbital- Methadone
K143535 · DIS
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 29d
Cleared Dec 18, 2014
CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine
K142609 · LFG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 93d
Cleared Oct 16, 2014
Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test...
K142280 · DJG
Healgen Scientific, LLC
Chemistry · 62d
Cleared Oct 07, 2014
First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test
K142353 · DIO
W.H.P.M., Inc.
Toxicology · 47d