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
841–864 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Jul 10, 2000
ONTRAK TESTCUP PRO-5, MODEL 1986678
K001356 · DJC
Roche Diagnostics Corp.
Toxicology · 73d
Cleared Jul 10, 2000
INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST
K994409 · DPK
Alfa Scientific Designs, Inc.
Toxicology · 195d
Cleared Jul 05, 2000
INSTANT-VIEW MORPHINE URINE CASSETTE TEST
K994404 · DPK
Alfa Scientific Designs, Inc.
Toxicology · 190d
Cleared Jun 29, 2000
ONTRAK TESTCUP 502, MODEL 3016641
K001417 · DKZ
Roche Diagnostics Corp.
Toxicology · 55d
Cleared Jun 23, 2000
FIRST CHECK HOME DRUG TEST (THC)
K993663 · LDJ
Worldwide Medical Corp.
Toxicology · 238d
Cleared Jun 23, 2000
FIRST CHECK HOME DRUG TEST PANEL 3
K994138 · LDJ
Worldwide Medical Corp.
Toxicology · 199d
Cleared Jun 23, 2000
FIRST CHECK HOME DRUG TEST PANEL 2
K994139 · LDJ
Worldwide Medical Corp.
Toxicology · 199d
Cleared Jun 21, 2000
INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST
K994410 · LDJ
Alfa Scientific Designs, Inc.
Toxicology · 176d
Cleared Jun 20, 2000
ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10
K001286 · DIC
Diagnostic Chemicals , Ltd.
Toxicology · 60d
Cleared Jun 19, 2000
ADVANTAGE THC TEST
K001567 · LDJ
Advantage Diagnostics Corp.
Toxicology · 31d
Cleared Jun 09, 2000
CEDIA DAU 6-ACETYLMORPHINE ASSAY
K001178 · DJG
Microgenics Corp.
Toxicology · 59d
Cleared Jun 02, 2000
INSTANT-VIEW MARIJUANA URINE CASSETTE TEST
K994405 · DKE
Alfa Scientific Designs, Inc.
Toxicology · 157d
Cleared May 26, 2000
QUICKSCREEN PRO DRUG CUP, MODEL 9195X
K001397 · DKZ
Phamatech
Toxicology · 23d
Cleared May 17, 2000
ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U.
K001225 · DKZ
Princeton BioMeditech Corp.
Toxicology · 30d
Cleared May 15, 2000
STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541
K000399 · LCM
OraSure Technologies, Inc.
Toxicology · 98d
Cleared May 11, 2000
COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA
K001197 · DIO
OraSure Technologies, Inc.
Toxicology · 30d
Cleared May 05, 2000
SYNCHRON SYSTEMS AMPHETAMINE REAGENT
K000606 · DKZ
Beckman Coulter, Inc.
Toxicology · 72d
Cleared May 02, 2000
CEDIA DAU AMPHASSURE ASSAY
K994380 · DKZ
Microgenics Corp.
Toxicology · 127d
Cleared Apr 26, 2000
ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
K000096 · LAF
Roche Diagnostics Corp.
Toxicology · 104d
Cleared Apr 24, 2000
SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST
K000452 · LAF
Drug Detection Devices, Ltd.
Toxicology · 73d
Cleared Apr 18, 2000
SCREENERS AMPHETAMINE TEST, DRUGSCREEN DIP AMPHETAMINE TEST
K000400 · DKZ
Drug Detection Devices, Ltd.
Toxicology · 71d
Cleared Apr 18, 2000
SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST
K000402 · LCM
Drug Detection Devices, Ltd.
Toxicology · 71d
Cleared Apr 18, 2000
SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST
K000522 · DIS
Drug Detection Devices, Ltd.
Toxicology · 62d
Cleared Apr 17, 2000
URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
K000458 · JXM
Dade Behring, Inc.
Toxicology · 66d