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
1705–1728 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III
K911178 · JJX
Analytical Control Systems, Inc.
Toxicology · 44d
Cleared Apr 16, 1991
OPUS FSH
K911409 · CGJ
Pb Diagnostic Systems, Inc.
Toxicology · 15d
Cleared Apr 12, 1991
UTAK LABORATORIES TOXICOLOGY CONTROL
K903061 · LAS
Utak Laboratories, Inc.
Toxicology · 277d
Cleared Apr 09, 1991
USCI ILLUMEN-8 8F PTCA GUIDING CATHETER
K910154 · DOY
C.R. Bard, Inc.
Toxicology · 85d
Cleared Apr 08, 1991
EQUIPMENT/MATERIAL DECONTAMINATING KIT
K911299 · KIE
Rohm and Haas Co.
Toxicology · 14d
Cleared Apr 05, 1991
MICROLINE SCREEN FOR METHAMPHETAMINE
K910525 · DIT
Drug Screening Systems, Inc.
Toxicology · 57d
Cleared Apr 05, 1991
ABUSCREEN ONTRAK FOR BENZODIAZEPINE
K910590 · JXM
Roche Diagnostic Systems, Inc.
Toxicology · 52d
Cleared Apr 03, 1991
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINE(500 NG/ML)
K910278 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Apr 03, 1991
IL PHENOBARBITAL ASSAY SYSTEM
K910355 · DLZ
Instrumentation Laboratory CO
Toxicology · 64d
Cleared Apr 03, 1991
ABUSCREEN FP FOR CANNABINOIDS (50-100)
K910589 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Apr 03, 1991
ABUSCREEN ONTRAK FOR METHAMPHETAMINE
K910658 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 48d
Cleared Apr 03, 1991
LYPHOCHEK BENZO/TCA CONTROL SERUM, LEVELS 1 AND 2
K910829 · LAS
Bio-Rad
Toxicology · 35d
Cleared Apr 03, 1991
TARGET(TM) CANNABINOIDS-V TEST
K910892 · LDJ
V-Tech, Inc.
Toxicology · 30d
Cleared Apr 03, 1991
TARGET(TM) CANNABINOIDS-R TEST
K910893 · LDJ
V-Tech, Inc.
Toxicology · 30d
Cleared Apr 03, 1991
DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD
K911056 · DIP
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 26d
Cleared Mar 21, 1991
CEDIA(R) DIGOXIN SC ASSAY
K910642 · KXT
Microgenics Corp.
Toxicology · 36d
Cleared Mar 21, 1991
TARGET AMPHETAMINE/METHAMPHETAMINE-R (READER METH)
K910739 · DKZ
V-Tech, Inc.
Toxicology · 28d
Cleared Mar 19, 1991
TARGET COCAINE METABOLITE-V
K910123 · KLN
V-Tech, Inc.
Toxicology · 67d
Cleared Mar 19, 1991
TARGET AMPHETAMINE/METHAMPHETAMINE-V (VISUAL METH)
K910738 · DKZ
V-Tech, Inc.
Toxicology · 26d
Cleared Mar 14, 1991
EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE
K910527 · DJD
Syva Co.
Toxicology · 35d
Cleared Mar 13, 1991
ON-SITE ALCOHOL
K903223 · DOJ
Toxi-Lab, Inc.
Toxicology · 233d
Cleared Mar 13, 1991
MICROLINE SCREEN FOR OPIATES
K905491 · DJG
Drug Screening Systems, Inc.
Toxicology · 96d
Cleared Mar 11, 1991
ABUSCREEN ONLINE CANNABINOIDS CALIBRATORS
K910085 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 62d
Cleared Mar 11, 1991
ABUSCREEN(R) ONLINE CONTROLS
K910689 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 20d