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
553–576 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Feb 09, 2004
URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A
K033713 · DIO
Dade Behring, Inc.
Toxicology · 75d
Cleared Jan 20, 2004
ONTRAK TESTCUP II AND ONSITE CUPKIT
K033902 · DKZ
Varian, Inc.
Toxicology · 34d
Cleared Jan 12, 2004
ROCHE ONLINE TDM QUINIDINE
K032332 · LBZ
Roche Diagnostics Corp.
Toxicology · 167d
Cleared Jan 06, 2004
VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK
K033659 · DKZ
Varian, Inc.
Toxicology · 46d
Cleared Dec 19, 2003
INSTAREAD LITHIUM SYSTEM
K031579 · JIH
Akers Laboratories, Inc.
Toxicology · 213d
Cleared Dec 19, 2003
ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161...
K033094 · DKZ
Lin-Zhi International, Inc.
Toxicology · 81d
Cleared Dec 12, 2003
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE
K033299 · LAF
ACON Laboratories, Inc.
Toxicology · 59d
Cleared Dec 12, 2003
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454
K033366 · DIF
Bio-Rad
Toxicology · 52d
Cleared Dec 12, 2003
LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES)
K033404 · DIF
Bio-Rad
Toxicology · 49d
Cleared Dec 02, 2003
PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS
K033246 · DLJ
Roche Diagnostics Corp.
Toxicology · 56d
Cleared Nov 24, 2003
CEDIA VANCOMYCIN ASSAY
K032811 · LEH
Microgenics Corp.
Toxicology · 76d
Cleared Nov 10, 2003
PROFILE -ER
K033334 · DIS
Medtox Diagnostics, Inc.
Toxicology · 25d
Cleared Nov 03, 2003
BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT)
K032764 · DIS
Lin-Zhi International, Inc.
Toxicology · 59d
Cleared Oct 17, 2003
AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST
K031497 · DJC
Amedica Biotech, Inc.
Toxicology · 157d
Cleared Oct 10, 2003
METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT),...
K031797 · DJR
Lin-Zhi International, Inc.
Toxicology · 122d
Cleared Oct 10, 2003
ONLINE TDM AMIKA
K032279 · KLP
Roche Diagnostics Corp.
Toxicology · 78d
Cleared Oct 09, 2003
MAS PAR TDM
K032826 · DIF
Medical Analysis Systems, Inc.
Toxicology · 29d
Cleared Oct 06, 2003
DIMENSION DRUG CALIBRATOR II, MODEL DC49C
K032574 · DKB
Dade Behring, Inc.
Toxicology · 47d
Cleared Oct 03, 2003
ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221
K032461 · DIC
Lin-Zhi International, Inc.
Toxicology · 53d
Cleared Sep 29, 2003
AML HAIRCHECK-DT (COCAINE)
K023626 · DIO
Quest Diagnostics, Inc.
Toxicology · 335d
Cleared Sep 17, 2003
ONLINE TDM CARBAMAZEPINE
K031902 · KLT
Roche Diagnostics Corp.
Toxicology · 89d
Cleared Sep 15, 2003
LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK...
K023837 · LAF
Princeton BioMeditech Corp.
Toxicology · 301d
Cleared Sep 05, 2003
BENZODIAZEPINE ENZYME IMMUNOASSAY
K032365 · JXM
Lin-Zhi International, Inc.
Toxicology · 36d
Cleared Aug 27, 2003
DRI METHADONE METABOLITE ENZYME IMMUNOASSAY
K023617 · DJR
Microgenics Corp.
Toxicology · 302d