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
1729–1752 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Mar 11, 1991
ABUSCREEN(R) FP FOR METHAMPHETAMINE (500-1000)
K910756 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 20d
Cleared Feb 27, 1991
COBAS ALPHA
K910222 · JJG
Roche Diagnostic Systems, Inc.
Toxicology · 40d
Cleared Feb 27, 1991
PHOSPHORUS (INORGANIC) TEST SYSTEM
K910296 · CEO
Biochemical Trade, Inc.
Toxicology · 35d
Cleared Feb 26, 1991
ALBUMIN REAGENT SET
K905776 · CJW
Biochemical Trade, Inc.
Toxicology · 61d
Cleared Feb 22, 1991
EMIT II BENZODIAZEPINE ASSAY
K910376 · JXM
Syva Co.
Toxicology · 24d
Cleared Feb 21, 1991
OPUS GENTAMICIN
K905721 · LCQ
Pb Diagnostic Systems, Inc.
Toxicology · 62d
Cleared Feb 14, 1991
TENONE(TM) METHAMPHETAMINE
K910043 · LAF
Diagnostic Products Corp.
Toxicology · 41d
Cleared Feb 13, 1991
MILENIA COCAINE METABOLITE
K910044 · KLN
Diagnostic Products Corp.
Toxicology · 40d
Cleared Feb 04, 1991
EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS
K904990 · LBZ
Syva Co.
Toxicology · 90d
Cleared Feb 04, 1991
OPUS T3 TEST SYSTEM
K905410 · CDP
Pb Diagnostic Systems, Inc.
Toxicology · 63d
Cleared Feb 04, 1991
ABUSCREEN(R) ONLINE CALIBRATORS
K905828 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 48d
Cleared Feb 04, 1991
ABUSCREEN ONLINE OPIATES CALIBRATORS
K910087 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 27d
Cleared Feb 01, 1991
FIRM MASTER
K905195 · LKY
Bak Medical Products
Toxicology · 74d
Cleared Jan 17, 1991
DE-TOX TUBES A AND DE-TOX TUBES B
K904326 · DPA
Dyna-Tek Industries
Toxicology · 119d
Cleared Jan 17, 1991
THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM
K904816 · CDX
Bd Becton Dickinson Vacutainer...
Toxicology · 85d
Cleared Jan 17, 1991
CEDIA PHENYTOIN ASSAY
K905689 · DIP
Microgenics Corp.
Toxicology · 29d
Cleared Jan 17, 1991
ECLIPSE ICA DIGOXIN
K905719 · DPO
Biotope, Inc.
Toxicology · 27d
Cleared Jan 17, 1991
ABUSCREEN ONLINE COCAINE METABOLITE CALIBRATORS
K910086 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 9d
Cleared Jan 15, 1991
EZ-SCREEN: AMPHETAMINES
K905700 · DKZ
Environmental Diagnostics, Inc.
Toxicology · 26d
Cleared Jan 15, 1991
ABUSCREEN ONTRAK FOR COCAINE (200NG/ML)
K905730 · KLN
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Jan 11, 1991
ABUSCREEN ONLINE TM FOR THC
K904996 · LAT
Roche Diagnostic Systems, Inc.
Toxicology · 65d
Cleared Dec 27, 1990
ABUSCREEN ONLINE TM FOR OPIATES
K904997 · DJG
Roche Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Dec 26, 1990
EMIT(R) II CANNABINOID 100 NG ASSAY
K904568 · LDJ
Syva Co.
Toxicology · 78d
Cleared Dec 26, 1990
EMIT(R) II 9 CANNABINOID NEGATIVE CALIBRA/CONTROLS
K904569 · DLJ
Syva Co.
Toxicology · 78d