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
937–960 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Sep 02, 1999
DRUGCHECK X MULTIDRUG SCREENING DEVICE
K992748 · DIO
Syntron Bioresearch, Inc.
Toxicology · 17d
Cleared Aug 30, 1999
CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3
K992430 · JJT
Medical Analysis Systems, Inc.
Toxicology · 40d
Cleared Aug 26, 1999
URINE DRUG SCREENING CONTROL
K992395 · DIF
Seracare Technology
Toxicology · 38d
Cleared Aug 25, 1999
REDI-TEST PCP
K991698 · LCM
Redwood Biotech, Inc.
Toxicology · 99d
Cleared Aug 19, 1999
OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2
K992086 · JIX
Olympus America, Inc.
Toxicology · 59d
Cleared Aug 10, 1999
ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3
K992422 · DJG
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Aug 05, 1999
MICRO-STRIP FOR PHENCYCLIDINE METABOLITES
K991505 · LCM
Microdiagnostics, Inc.
Toxicology · 98d
Cleared Aug 05, 1999
MICRO-STRIP FOR MARIJUANA METABOLITES
K991516 · LDJ
Microdiagnostics, Inc.
Toxicology · 97d
Cleared Jul 28, 1999
MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965,...
K991702 · JKA
Becton Dickinson Vacutainer Systems
Toxicology · 70d
Cleared Jul 26, 1999
REDI-TEST COCAINE
K991110 · DIO
Redwood Biotech, Inc.
Toxicology · 116d
Cleared Jul 22, 1999
REDI-TEST METHAMPHETAMINE
K991504 · LAF
Redwood Biotech, Inc.
Toxicology · 84d
Cleared Jul 22, 1999
COBAS INTEGRA AMIKACIN MAB
K991597 · LGJ
Roche Diagnostics Corp.
Toxicology · 73d
Cleared Jul 22, 1999
COBAS INTEGRA ACETAMINOPHEN
K991598 · LDP
Roche Diagnostics Corp.
Toxicology · 73d
Cleared Jul 22, 1999
QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM
K992207 · DIO
Syntron Bioresearch, Inc.
Toxicology · 22d
Cleared Jul 15, 1999
DBSET MULTIDRUG SCREEN TEST KIT
K990681 · DKZ
Ameritek, Inc.
Toxicology · 135d
Cleared Jul 15, 1999
RAPIDONE - OPIATES TEST
K990820 · DJG
American Bio Medica Corp.
Toxicology · 126d
Cleared Jul 15, 1999
RAPIDONE - COCAINE TEST
K990822 · DIO
American Bio Medica Corp.
Toxicology · 126d
Cleared Jul 14, 1999
REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE
K992151 · LAS
Consolidated Technologies, Inc.
Toxicology · 20d
Cleared Jul 13, 1999
ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS
K992163 · DOP
Pdz-Europa , Ltd.
Toxicology · 18d
Cleared Jul 13, 1999
AT HOME DRUG TEST, MODEL 9175
K992217 · MVO
Phamatech
Toxicology · 12d
Cleared Jul 07, 1999
RAPIDONE - MARIJUANA TEST
K990818 · LDJ
American Bio Medica Corp.
Toxicology · 118d
Cleared Jul 06, 1999
STATUS STIK, ACCUSIGN STIK
K992068 · DKE
Princeton BioMeditech Corp.
Toxicology · 18d
Cleared Jun 30, 1999
MODIFICATION TO 'RAPID DRUG SCREEN' 9-PANEL
K992033 · DKZ
American Bio Medica Corp.
Toxicology · 14d
Cleared Jun 28, 1999
BIONIKE AQ BARBITURATE TEST
K990280 · DIS
Bionike, Inc.
Toxicology · 151d