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
1897–1920 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Aug 25, 1989
ADX TM BARBITURATES
K890690 · DIS
Abbott Laboratories
Toxicology · 192d
Cleared Aug 25, 1989
ADX TM BENZODIAZEPINES
K890691 · JXM
Abbott Laboratories
Toxicology · 192d
Cleared Aug 25, 1989
ADX AMPHETAMINE/METHAMPHEAMINE
K890692 · DKZ
Abbott Laboratories
Toxicology · 196d
Cleared Aug 25, 1989
ADX CANNABINOIDS
K890693 · LDJ
Abbott Laboratories
Toxicology · 196d
Cleared Aug 25, 1989
ADX COCAINE METABOLITE
K890788 · DIO
Abbott Laboratories
Toxicology · 191d
Cleared Aug 21, 1989
EMIT CONVENIENCE PACK: DIGOXIN ASSAY
K893910 · KXT
Syva Co.
Toxicology · 83d
Cleared Aug 21, 1989
TECHNICON RA SYSTEMS GENTAMICIN TEST METHOD
K893912 · LCD
Technicon Instruments Corp.
Toxicology · 83d
Cleared Aug 21, 1989
TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD
K893913 · KLB
Technicon Instruments Corp.
Toxicology · 83d
Cleared Aug 21, 1989
LIQUID CHROMATOGRAPHY COLUMNS
K894141 · DPM
Supelco, Inc.
Toxicology · 69d
Cleared Aug 21, 1989
ABUSCREEN TRI-LEVEL REFERENCE CONTROLS
K894463 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 32d
Cleared Aug 15, 1989
COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS
K891581 · LEG
Roche Diagnostic Systems, Inc.
Toxicology · 148d
Cleared Aug 15, 1989
AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT
K893469 · CEE
Amersham Corp.
Toxicology · 103d
Cleared Aug 15, 1989
ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE
K894465 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 26d
Cleared Aug 11, 1989
EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE
K894404 · DKZ
Syva Co.
Toxicology · 25d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR BARBITUATES
K893855 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR MORPHINE
K893856 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR AMPHETAMINE
K893857 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REFERENCE CONTROL FOR THC
K893858 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR COCAINE
K893859 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE
K893860 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
OPUS IMMUNOASSAY SYSTEM
K894159 · KHO
Pb Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Aug 03, 1989
EMIT D.A.U. LOW & MEDIUM CALIBRATOR A
K894327 · DKG
Syva Co.
Toxicology · 20d
Cleared Jul 25, 1989
HYCOR SENTRY(TM) DRUGS OF ABUSE URINE CALIBRATORS
K893815 · DKB
Hycor Biomedical, Inc.
Toxicology · 63d
Cleared Jun 22, 1989
MODIFIED GELMAN ARTERIAL FILTER
K892387 · DTM
Gelman Sciences, Inc.
Toxicology · 69d