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
817–840 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Nov 29, 2000
FIRST CHECK HOME DRUG TEST PANEL 4
K993852 · LAF
Worldwide Medical Corp.
Toxicology · 383d
Cleared Nov 27, 2000
BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST
K002263 · LDJ
Branan Medical Corp.
Toxicology · 125d
Cleared Nov 27, 2000
BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST
K002264 · DIO
Branan Medical Corporation
Toxicology · 125d
Cleared Nov 27, 2000
BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST
K002265 · DJC
Branan Medical Corporation
Toxicology · 125d
Cleared Nov 27, 2000
BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST
K002268 · DJG
Branan Medical Corporation
Toxicology · 125d
Cleared Nov 27, 2000
BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST
K002342 · JXM
Branan Medical Corporation
Toxicology · 118d
Cleared Nov 27, 2000
SYNCHRON CONTROL
K003488 · JJY
Beckman Coulter, Inc.
Toxicology · 14d
Cleared Nov 22, 2000
BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST
K002266 · DKZ
Branan Medical Corporation
Toxicology · 120d
Cleared Nov 22, 2000
BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D
K002272 · LCM
Branan Medical Corp.
Toxicology · 119d
Cleared Nov 22, 2000
BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST
K002337 · DIS
Branan Medical Corporation
Toxicology · 113d
Cleared Nov 22, 2000
BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C...
K002417 · DJR
Branan Medical Corporation
Toxicology · 106d
Cleared Nov 22, 2000
BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C...
K002418 · DOE
Branan Medical Corporation
Toxicology · 106d
Cleared Nov 22, 2000
BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST
K002587 · DJC
Branan Medical Corporation
Toxicology · 93d
Cleared Nov 16, 2000
MODIFICATION TO RAPID DRUG SCREEN 9-PANEL
K002447 · DKZ
American Bio Medica Corp.
Toxicology · 99d
Cleared Sep 28, 2000
MODIFICATION TO PROFILE -II
K002776 · LCM
Medtox Diagnostics, Inc.
Toxicology · 22d
Cleared Sep 26, 2000
CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80
K002354 · KHS
Diagnostic Chemicals , Ltd.
Toxicology · 55d
Cleared Aug 14, 2000
INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST
K994403 · DIO
Alfa Scientific Designs, Inc.
Toxicology · 230d
Cleared Aug 14, 2000
INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST
K994406 · DJC
Alfa Scientific Designs, Inc.
Toxicology · 230d
Cleared Aug 07, 2000
PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST
K001126 · LDJ
Alatex Scientific, Inc.
Toxicology · 122d
Cleared Aug 07, 2000
INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST
K994395 · DKZ
Alfa Scientific Designs, Inc.
Toxicology · 223d
Cleared Aug 04, 2000
INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST
K994399 · DKZ
Alfa Scientific Designs, Inc.
Toxicology · 220d
Cleared Aug 04, 2000
INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST
K994400 · DJC
Alfa Scientific Designs, Inc.
Toxicology · 220d
Cleared Jul 27, 2000
INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST
K994398 · DIO
Alfa Scientific Designs, Inc.
Toxicology · 212d
Cleared Jul 12, 2000
ONTRAK TESTCUP 501, MODEL 3016633
K001421 · DKZ
Roche Diagnostics Corp.
Toxicology · 68d