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
1777–1800 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Sep 27, 1990
COULOCHEM II
K903231 · LEQ
Esa, Inc.
Toxicology · 66d
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