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
1129–1152 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Jul 14, 1997
QUIKSTRIP ONE STEP COCAINE TEST
K971926 · DIO
Drial Consultants, Inc.
Toxicology · 48d
Cleared Jul 14, 1997
INNOFLUOR PHENOBARBITAL ASSAY SYSTEM
K972330 · LGQ
Oxis Intl., Inc.
Toxicology · 21d
Cleared Jul 03, 1997
ONE STEP MARIJUANA CARD TEST
K970548 · LDJ
Teco Diagnostics
Toxicology · 141d
Cleared Jul 03, 1997
ONE STEP MORPHINE CARD TEST
K970579 · DNK
Teco Diagnostics
Toxicology · 139d
Cleared Jun 26, 1997
QUIKSTRIP ONE STEP METHAMPHETAMINE
K970395 · DKZ
Drial Consultants, Inc.
Toxicology · 143d
Cleared Jun 25, 1997
EMIT II OPIATES 300/2000 ASSAY
K971596 · DJG
Behring Diagnostics, Inc.
Toxicology · 55d
Cleared Jun 25, 1997
EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)
K971600 · DKB
Behring Diagnostics, Inc.
Toxicology · 55d
Cleared Jun 25, 1997
BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST
K971841 · LDJ
Bionike Laboratories, Inc.
Toxicology · 37d
Cleared Jun 24, 1997
LYPHOCHEK REMEDI CONTROL
K972174 · DIF
Bio-Rad
Toxicology · 15d
Cleared Jun 11, 1997
N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K971713 · LAN
Bayer Corp.
Toxicology · 33d
Cleared Jun 06, 1997
AQ OPIATES (MORPHINE) TEST
K971361 · DJG
Bionike Laboratories, Inc.
Toxicology · 56d
Cleared Jun 03, 1997
SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR
K971506 · DMT
Beckman Instruments, Inc.
Toxicology · 39d
Cleared May 30, 1997
QUIKSTRIP ONE STEP AMPHETAMINE TEST
K971218 · DKZ
Drial Consultants, Inc.
Toxicology · 58d
Cleared May 30, 1997
LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3
K971691 · DIF
Bio-Rad
Toxicology · 23d
Cleared May 21, 1997
CEDIA DIGOXIN II
K970883 · KXT
Boehringer Mannheim Corp.
Toxicology · 72d
Cleared May 21, 1997
SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL
K971534 · DIF
Beckman
Toxicology · 23d
Cleared May 14, 1997
CEDIA DIGOXIN
K970881 · KXT
Boehringer Mannheim Corp.
Toxicology · 65d
Cleared May 14, 1997
QUIKPAC II ONE STEP AMPHETAMINE TEST
K971109 · DKZ
Drial Consultants, Inc.
Toxicology · 49d
Cleared May 13, 1997
QUICKPAC II ONE STEP METHAMPHETAMINE TEST
K970724 · DKZ
Drial Consultants, Inc.
Toxicology · 75d
Cleared May 12, 1997
INNOFLOUR CALIBRATOR REAGENT SET
K970509 · DLJ
Oxis Intl., Inc.
Toxicology · 90d
Cleared May 12, 1997
INNOFLOUR TOPIRAMATE REAGENT SET
K970510 · MSL
Oxis Intl., Inc.
Toxicology · 90d
Cleared May 12, 1997
INNOFLUOR TOPIRAMATE CONTROL SET
K970517 · LAS
Oxis Intl., Inc.
Toxicology · 90d
Cleared May 12, 1997
GREINER VACUETTE BLOOD COLLECTION TUBE
K971236 · JKA
Greiner America, Inc.
Toxicology · 40d
Cleared May 08, 1997
SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS
K971287 · DKB
Beckman Instruments, Inc.
Toxicology · 31d