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
1633–1656 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Dec 18, 1991
COCAINE METABOLITE EIA TEST
K915371 · DIO
Diagnostic Reagents, Inc.
Toxicology · 21d
Cleared Dec 10, 1991
MICRO EIA FOR COCAINE METABOLITES
K914533 · DIO
Microdiagnostics, Inc.
Toxicology · 60d
Cleared Dec 10, 1991
CHROMATOGRAPHY CLINICAL USE 75JQR
K914841 · KIE
Millipore Corp.
Toxicology · 46d
Cleared Dec 09, 1991
PHENCYCLIDINE EIA ASSAY
K915179 · LCM
Diagnostic Reagents, Inc.
Toxicology · 24d
Cleared Dec 03, 1991
IL TEST(TM) COCAINE
K913737 · JXO
Instrumentation Laboratory CO
Toxicology · 105d
Cleared Nov 29, 1991
MICRO EIA FOR MARIJUANA METABOLITES
K914490 · LDJ
Microdiagnostics, Inc.
Toxicology · 52d
Cleared Nov 29, 1991
SYVA EMIT D.A.U. COCAINE METABOLITE
K914973 · DIO
Syva Co.
Toxicology · 23d
Cleared Nov 29, 1991
EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH)
K915003 · DKB
Syva Co.
Toxicology · 22d
Cleared Nov 22, 1991
LIQUICHEK THERAPEUTIC DRUG MONITORING CONTROL(TDM)
K914170 · DIF
Bio-Rad
Toxicology · 66d
Cleared Nov 22, 1991
IMMULITE DIGOXIN
K914833 · DPO
Cirrus Diagnostics, Inc.
Toxicology · 28d
Cleared Nov 19, 1991
ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL
K914806 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 26d
Cleared Nov 07, 1991
IL TEST(TM) AMPHETAMINE
K913738 · DKZ
Instrumentation Laboratory CO
Toxicology · 79d
Cleared Nov 07, 1991
IL TEST(TM) OPIATE
K913742 · DJG
Instrumentation Laboratory CO
Toxicology · 79d
Cleared Nov 07, 1991
IL TEST(TM) PHENCYCLIDINE
K913743 · LCM
Instrumentation Laboratory CO
Toxicology · 79d
Cleared Nov 07, 1991
OPUS(R) LH TEST SYSTEM
K913938 · CEP
Pb Diagnostic Systems, Inc.
Toxicology · 65d
Cleared Nov 01, 1991
ABUSCREEN(R) RADIOIMMUNOASSAY FOR METHAMPHE/AMPHET
K913911 · DPJ
Roche Diagnostic Systems, Inc.
Toxicology · 63d
Cleared Nov 01, 1991
ABUSCREEN(R) ONLINE(TM) FOR BENZODIAZEPINES
K914509 · JXM
Roche Diagnostic Systems, Inc.
Toxicology · 23d
Cleared Oct 30, 1991
ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES
K914468 · DKN
Roche Diagnostic Systems, Inc.
Toxicology · 23d
Cleared Oct 21, 1991
IL TEST(TM) DAT CAL/CONTROL SET B
K913740 · DKB
Instrumentation Laboratory CO
Toxicology · 62d
Cleared Oct 21, 1991
IL TEST(TM) DAT CAL/CONTROL SET C
K913741 · DKB
Instrumentation Laboratory CO
Toxicology · 62d
Cleared Oct 11, 1991
PCP DIRECT RIA KIT (I-125)
K913864 · LCL
Immunalysis Corporation
Toxicology · 45d
Cleared Oct 11, 1991
BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE
K914146 · DKZ
Biosite Incorporated
Toxicology · 25d
Cleared Sep 27, 1991
ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE
K912754 · DPJ
Roche Diagnostic Systems, Inc.
Toxicology · 98d
Cleared Sep 27, 1991
CEDIA(R) GENTAMICIN ASSAY
K913470 · LCD
Microgenics Corp.
Toxicology · 53d