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
1945–1968 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Feb 10, 1989
DETECTABUSE DRUG CONTROLS
K890406 · DIF
Eastern Laboratories, Ltd.
Toxicology · 17d
Cleared Feb 10, 1989
EMIT(R) D.A.U AMPHETAMINE CLASS LOW CALIBRATOR
K890451 · DLJ
Syva Co.
Toxicology · 11d
Cleared Feb 10, 1989
EMIT(R) D.A.U. AMPHETAMINE CLASS MEDIUM CALIBRATOR
K890452 · DLJ
Syva Co.
Toxicology · 11d
Cleared Feb 07, 1989
CRACK-IT CHAP SCREEN
K874389 · DMN
Sakers, Inc.
Toxicology · 469d
Cleared Feb 07, 1989
CEDIA THEOPHYLLINE ASSAY
K884358 · KLS
Microgenics Corp.
Toxicology · 113d
Cleared Feb 02, 1989
SOURCERER
K884091 · JJJ
John Caunt Scientific , Ltd.
Toxicology · 127d
Cleared Jan 30, 1989
ACA DU PONT METHOTREXATE (MTHO) METHOD
K884744 · LAO
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 77d
Cleared Jan 30, 1989
DU PONT ACA METHOTREXATE CALIBRATOR
K884745 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 77d
Cleared Jan 24, 1989
ACA ETHYL ALCOHOL (ALC) ANALYTICAL TEST PACKS
K881344 · DIC
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 300d
Cleared Jan 24, 1989
DOUBLE ANTIBODY SERUM BENZODIAZEPINES
K890001 · JXM
Diagnostic Products Corp.
Toxicology · 21d
Cleared Jan 23, 1989
COAT-A-COUNT (TM) THEOPHYLLINE
K890002 · KLS
Diagnostic Products Corp.
Toxicology · 20d
Cleared Jan 23, 1989
NEW LOW LEVEL DRUG MIXTURE CONTROL
K890030 · DIF
Rapid Diagnostic Laboratories, Inc.
Toxicology · 19d
Cleared Jan 09, 1989
COAT-A-COUNT METHAMPHETAMIN #TKMA1
K885071 · LAF
Diagnostic Products Corp.
Toxicology · 32d
Cleared Dec 29, 1988
BEHRING POLAROID OPUS THEOPHYLLINE
K885044 · KLS
Pb Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Dec 22, 1988
LIQUID CHROMATOGRAPHY COLUMNS SOLID PHASE EX. TUBE
K884403 · DPM
Supelco, Inc.
Toxicology · 64d
Cleared Dec 16, 1988
EZ-SCREEN CANNABINOID/COCAINE
K883105 · DIO
Environmental Diagnostics, Inc.
Toxicology · 144d
Cleared Dec 16, 1988
LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73
K883615 · DJY
Supelco, Inc.
Toxicology · 114d
Cleared Dec 16, 1988
TDX METHADONE ASSAY
K884968 · DJR
Abbott Laboratories
Toxicology · 16d
Cleared Nov 29, 1988
TDX BENZODIAZEPINES SERUM
K883730 · JXM
Abbott Laboratories
Toxicology · 90d
Cleared Nov 22, 1988
TECHNICON RA-PHENOBARBITAL
K884419 · DLZ
Technicon Instruments Corp.
Toxicology · 33d
Cleared Nov 16, 1988
ANALYST THEOPHYLLINE CALIBRATOR
K884170 · DLJ
The DU Pont Co.
Toxicology · 56d
Cleared Nov 10, 1988
TURBOX THEOPHYLLINE ASSAY
K882570 · LER
Unipath , Ltd.
Toxicology · 141d
Cleared Nov 10, 1988
HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL
K883942 · JJY
Icl Scientific
Toxicology · 52d
Cleared Oct 31, 1988
ANALYST THEOPHYLLINE ROTOR
K884002 · KLS
The DU Pont Co.
Toxicology · 40d