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
913–936 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Dec 30, 1999
AT HOME DRUG TEST, MODEL 9078
K994220 · LDJ
Phamatech
Toxicology · 15d
Cleared Dec 30, 1999
AT HOME DRUG TEST, MODEL 9068
K994233 · LAF
Phamatech
Toxicology · 14d
Cleared Dec 30, 1999
AT HOME DRUG TEST, MODEL 9083
K994234 · DJG
Phamatech
Toxicology · 14d
Cleared Dec 30, 1999
AT HOME DRUG TEST, MODEL 9133
K994236 · LCM
Phamatech
Toxicology · 14d
Cleared Dec 30, 1999
AT HOME DRUG TEST, MODEL 9063
K994237 · DKZ
Phamatech
Toxicology · 14d
Cleared Dec 27, 1999
SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST
K992949 · LDJ
Drug Detection Devices, Ltd.
Toxicology · 117d
Cleared Dec 21, 1999
BIO-RAD HOMOCYSTEINE BY HPLC
K993107 · LPS
Bio-Rad
Toxicology · 95d
Cleared Dec 21, 1999
EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5
K993755 · DKB
Syva Co.
Toxicology · 46d
Cleared Dec 21, 1999
RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA,...
K993796 · LDJ
American Bio Medica Corp.
Toxicology · 42d
Cleared Dec 16, 1999
VERDICT -II OPIATES 2000
K992111 · DJG
Medtox Diagnostics, Inc.
Toxicology · 177d
Cleared Dec 16, 1999
AT WORK DRUG TEST, MODEL 9145-25C
K994093 · LCL
Phamatech
Toxicology · 13d
Cleared Dec 10, 1999
DRUG STOP
K991465 · MVO
Texas Immunology, Inc.
Toxicology · 227d
Cleared Dec 07, 1999
BIONIKE AQ PHENCYCLIDINE (PCP) TEST
K993945 · LCM
Bionike Laboratories, Inc.
Toxicology · 18d
Cleared Nov 26, 1999
SYNCHRON SYSTEMS DRUG CALIBRATOR 2
K993473 · DLJ
Beckman Coulter, Inc.
Toxicology · 43d
Cleared Nov 23, 1999
ROCHE COBAS INTEGRA OPIATES 300/2000
K992890 · DJG
Roche Diagnostics Corp.
Toxicology · 88d
Cleared Nov 09, 1999
SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS
K993022 · DLJ
Beckman Coulter, Inc.
Toxicology · 61d
Cleared Oct 29, 1999
QUICKSTRIP ONE STEP OPIATES TEST
K993490 · DJG
Syntron Bioresearch, Inc.
Toxicology · 14d
Cleared Oct 29, 1999
QUICKPAC II ONE STEP OPIATES TEST
K993491 · DJG
Syntron Bioresearch, Inc.
Toxicology · 14d
Cleared Oct 20, 1999
QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178
K993165 · DJG
Phamatech
Toxicology · 28d
Cleared Oct 18, 1999
RAPIDONE-AMPHETAMINE TEST
K992452 · DOD
American Bio Medica Corp.
Toxicology · 88d
Cleared Oct 06, 1999
QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25C
K992685 · MVO
Phamatech
Toxicology · 57d
Cleared Oct 06, 1999
REDI-SCREEN
K993100 · DJC
Redwood Biotech, Inc.
Toxicology · 20d
Cleared Sep 20, 1999
QUICKPAC II ONE STEP COCAINE TEST
K992990 · DIO
Syntron Bioresearch, Inc.
Toxicology · 13d
Cleared Sep 15, 1999
REDI-TEST OPIATES
K991883 · DJG
Advantage Diagnostics Corp.
Toxicology · 105d