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
577–600 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Aug 22, 2003
ROCHE ONLINE TDM VALPROIC ACID
K032049 · LEG
Roche Diagnostics Corp.
Toxicology · 51d
Cleared Aug 21, 2003
TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC
K032057 · DIO
Branan Medical Corp.
Toxicology · 50d
Cleared Aug 20, 2003
ELECSYS PRECICONTROL TROPONIN T
K031990 · JJX
Roche Diagnostics Corp.
Toxicology · 54d
Cleared Aug 06, 2003
PRECISET TDM I AND PRECISET TDM II CALIBRATORS
K031856 · DKB
Roche Diagnostics Corp.
Toxicology · 51d
Cleared Aug 04, 2003
ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM...
K031759 · DKZ
ACON Laboratories, Inc.
Toxicology · 59d
Cleared Jul 23, 2003
EMIT II PLUS COCAINE METABOLITE ASSAY
K031512 · DIO
Dade Behring, Inc.
Toxicology · 70d
Cleared Jul 15, 2003
ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR
K031044 · KNK
Clinical Data, Inc.
Toxicology · 105d
Cleared Jul 15, 2003
SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT
K031870 · LEG
Beckman Coulter, Inc.
Toxicology · 28d
Cleared Jul 14, 2003
VERDICT II, PROFILE II
K031032 · DJG
Medtox Diagnostics, Inc.
Toxicology · 104d
Cleared Jul 11, 2003
A/C ENZYMATIC HOMOCYSTEINE ASSAY
K030754 · LPS
Anticancer, Inc.
Toxicology · 123d
Cleared Jul 02, 2003
MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE...
K030113 · DJG
Branan Medical Corp.
Toxicology · 170d
Cleared Jul 01, 2003
MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL
K031392 · DKC
Medical Analysis Systems, Inc.
Toxicology · 60d
Cleared Jun 13, 2003
RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016
K030211 · DKX
Icn Biomedicals, Inc.
Toxicology · 143d
Cleared Jun 06, 2003
SYVA EMIT II PLUS AMPHETAMINES ASSAY
K031004 · DKZ
Dade Behring, Inc.
Toxicology · 67d
Cleared May 22, 2003
DRI COTININE EIA ASSAY
K030649 · MRS
Microgenics Corp.
Toxicology · 83d
Cleared May 22, 2003
'RAPID ONE' - PROPOXYPHENE TEST
K030835 · JXN
American Bio Medica Corp.
Toxicology · 66d
Cleared May 14, 2003
COZART EIA COTININE URINE KIT
K021944 · MKU
Cozart Bioscience , Ltd.
Toxicology · 335d
Cleared May 06, 2003
VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF...
K023648 · LDJ
Sun Biomedical Laboratories, Inc.
Toxicology · 188d
Cleared Apr 30, 2003
'RAPIDTEC'-5M-MULTIPLE DIP TEST
K023869 · DJR
American Bio Medica Corp.
Toxicology · 161d
Not Cleared Apr 30, 2003
NIOX ARTICLE NO: 02-1000
DEN030001 · MXA
Aerocrine AB
Toxicology · 43d
Cleared Apr 29, 2003
SYNCHRON SYSTEMS OPIATE REAGENT
K031002 · DJG
Beckman Coulter, Inc.
Toxicology · 29d
Cleared Apr 28, 2003
COZART EIA COCAINE ORAL FLIUD KIT
K030234 · DIO
Cozart Bioscience , Ltd.
Toxicology · 95d
Cleared Apr 28, 2003
QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075
K030405 · LEG
Seradyn
Toxicology · 81d
Cleared Apr 28, 2003
ROCHE ONLINE TDM PHENYTOIN
K030428 · DIP
Roche Diagnostics Corp.
Toxicology · 77d