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
1825–1848 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Apr 12, 1990
MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR
K900705 · LBZ
Innotron of Oregon, Inc.
Toxicology · 59d
Cleared Apr 12, 1990
MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA
K900706 · LGS
Innotron of Oregon, Inc.
Toxicology · 59d
Cleared Apr 11, 1990
LYPHOCHEK URINE TOXICOLOGY CONTROL - CONFIRM
K901271 · DIF
Bio-Rad
Toxicology · 23d
Cleared Apr 09, 1990
PERKIN-ELMER AA 3100 ATOMIC ABSORPTION SPECTRO.
K900828 · JXR
The Perkin-Elmer Corp.
Toxicology · 47d
Cleared Apr 03, 1990
NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR
K900010 · JFT
Kallestad Diag, A Div. of Erbamont, Inc.
Toxicology · 91d
Cleared Mar 30, 1990
HYCOR ACCUPINCH MORPHINE TEST
K900173 · DJG
Hycor Biomedical, Inc.
Toxicology · 77d
Cleared Mar 29, 1990
NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET
K900009 · KLS
Kallestad Diag, A Div. of Erbamont, Inc.
Toxicology · 86d
Cleared Mar 29, 1990
HCG SOLID PHASE COMPONENT SYSTEM
K901045 · JHI
Bd Becton Dickinson Vacutainer...
Toxicology · 23d
Cleared Mar 28, 1990
POLYSTAN HEART-LUNG MACHINE SYSTEM
K894657 · DJQ
Polystan C/O Vitalcor, Inc.
Toxicology · 247d
Cleared Mar 23, 1990
MICRO DAU BENZODIAZEPINE ENZYME IMMUNOASSAY KIT
K896780 · JXM
Immunotech Corp.
Toxicology · 109d
Cleared Mar 23, 1990
MICRO DAU COCAINE METABOLITE TEST KIT
K896781 · DIO
Immunotech Corp.
Toxicology · 109d
Cleared Mar 19, 1990
OPUS T4 TEST SYSTEM
K897193 · KLI
Pb Diagnostic Systems, Inc.
Toxicology · 80d
Cleared Mar 09, 1990
MILENIA (TM) DIGITOXIN
K900013 · LFM
Diagnostic Products Corp.
Toxicology · 66d
Cleared Mar 09, 1990
ABUSCREEN FP FOR METHAMPHETAMINE
K900143 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 57d
Cleared Mar 09, 1990
EZ-SCREEN:OPIATES
K900203 · DJG
Environmental Diagnostics, Inc.
Toxicology · 52d
Cleared Mar 06, 1990
HYCOR ACCUPINCH COCAINE TEST
K896937 · DIO
Hycor Biomedical, Inc.
Toxicology · 83d
Cleared Feb 23, 1990
BENZODIAZEPINES/TRICYCLIC ANTIDEPRESSANTS BY HPLC
K896744 · JXM
Bio-Rad
Toxicology · 85d
Cleared Feb 23, 1990
BIOTRACK IMMUNOCHEMISTRY MONITOR
K900372 · JJQ
Biotrack, Inc.
Toxicology · 28d
Cleared Feb 13, 1990
DIGOXIN-EIA-XT
K896863 · KXT
In Vitro Diagnostics, Inc.
Toxicology · 69d
Cleared Feb 08, 1990
DADE(R) IMMUNOASSAY CONTROLS, LEVELS I, II, III
K892380 · DIF
Baxter Healthcare Corp
Toxicology · 308d
Cleared Feb 02, 1990
DADE(R) TDM CONTROL
K892642 · JJY
Baxter Healthcare Corp
Toxicology · 296d
Cleared Jan 26, 1990
ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)
K895906 · LCM
Roche Diagnostic Systems, Inc.
Toxicology · 112d
Cleared Jan 18, 1990
LYPHOCHEK WHOLE BLOOD CONTROL (HUMAN) LEVELS 1,2,3
K895905 · JJY
Bio-Rad
Toxicology · 104d
Cleared Jan 18, 1990
VISION THEOPHYLLINE II
K896927 · KLS
Abbott Laboratories
Toxicology · 37d