FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Toxicology ×
3,028 results
1777–1800 of 3,028
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Sep 27, 1990
DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY
K903824 · DKZ
Technicon Instruments Corp.
Toxicology · 38d
Cleared Sep 27, 1990
DRUG OF ABUSE ANALYSIS SYSTEM
K903825 · DIS
Technicon Instruments Corp.
Toxicology · 38d
Cleared Sep 17, 1990
IL GENTAMICIN ASSAY SYSTEM
K903743 · LCD
Instrumentation Laboratory CO
Toxicology · 32d
Cleared Sep 17, 1990
BIOTRACK THEOPHYLLINE QUALITY CONTROLS
K903924 · LAW
Biotrack, Inc.
Toxicology · 24d
Cleared Sep 14, 1990
BIOSITE DIAGNOSTICS OPIATE SCREENING TEST
K902924 · DJG
Biosite Incorporated
Toxicology · 74d
Cleared Aug 22, 1990
IL PHENYTOIN ASSAY SYSTEM
K902952 · DIP
Instrumentation Laboratory CO
Toxicology · 48d
Cleared Aug 22, 1990
INNOFLUOR (TM) AMIKACIN CALIBRATOR SET
K903101 · DLJ
Innotron of Oregon, Inc.
Toxicology · 40d
Cleared Aug 17, 1990
PENLON BREATHING SYSTEM PRESSURE MONITOR
K902381 · CAP
Penlon, Inc.
Toxicology · 79d
Cleared Aug 17, 1990
MILENIA(TM) PCP
K902960 · LCM
Diagnostic Products Corp.
Toxicology · 43d
Cleared Aug 17, 1990
EMIT ETHYL ALCOHOL CALIBRATORS AND CONTROLS
K903152 · DKB
Syva Co.
Toxicology · 30d
Cleared Aug 17, 1990
EMIT ETS PLUS ETHYL ALCOHOL ASSAY
K903228 · DMI
Syva Co.
Toxicology · 25d
Cleared Aug 09, 1990
SEROZYME FREE T3 IMMUNOASSAY
K902748 · KHQ
Advanced Magnetics, Inc.
Toxicology · 48d
Cleared Aug 09, 1990
INNOFLUOR (TM) AMIKACIN REAGENT SET
K903100 · KLQ
Innotron of Oregon, Inc.
Toxicology · 27d
Cleared Aug 09, 1990
EMIT ETHYL ALCOHOL ASSAY
K903153 · DIC
Syva Co.
Toxicology · 22d
Cleared Jul 27, 1990
EMIT(R) II OPIATE ASSAY
K902577 · DJG
Syva Co.
Toxicology · 46d
Cleared Jul 27, 1990
EMIT(R) II COCAINE METABOLITE ASSAY
K902579 · DIO
Syva Co.
Toxicology · 46d
Cleared Jul 27, 1990
EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE)
K902581 · DKB
Syva Co.
Toxicology · 46d
Cleared Jul 19, 1990
GENESYS 6000 GAMMA COUNTER
K900087 · JJJ
Laboratory Technologies, Inc.
Toxicology · 195d
Cleared Jul 19, 1990
EMIT(R) II BARBITURATE ASSAY
K902580 · DIS
Syva Co.
Toxicology · 38d
Cleared Jul 17, 1990
HYDRO-SIL(TM) COATED GUIDEWIRES
K900822 · DOX
National-Standard Medical Products
Toxicology · 146d
Cleared Jul 17, 1990
MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT
K902194 · DJG
Immunotech Corp.
Toxicology · 62d
Cleared Jul 10, 1990
TENONE(TM) OPIATES CATALOG: VKSO1,4
K902055 · DDE
Diagnostic Products Corp.
Toxicology · 64d
Cleared Jul 10, 1990
EMIT(R) II CALIBRATOR A LEVEL 1 & LEVEL 2
K902578 · DKB
Syva Co.
Toxicology · 29d
Cleared Jun 26, 1990
MODIFIED OPUS VALPROIC ACID TEST SYSTEM
K901538 · LEG
Pb Diagnostic Systems, Inc.
Toxicology · 85d