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
73–96 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Mar 31, 2023
BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug...
K230238 · DJG
Shenzhen Bioeasy Biotechnology Co., Ltd.
Toxicology · 60d
Cleared CT Mar 21, 2023
Genomadix Cube CYP2C19 System
K220026 · NTI
Genomadix, Inc.
Toxicology · 440d
Cleared Mar 17, 2023
Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug...
K223162 · LDJ
Healgen Scientific, LLC
Toxicology · 161d
Cleared Feb 06, 2023
Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
K222955 · DJG
Xenta Biomedical Science Co., Ltd.
Toxicology · 132d
Cleared Dec 23, 2022
ONLINE DAT Benzodiazepines II
K221765 · JXM
Roche Diagnostics
Toxicology · 189d
Cleared Dec 21, 2022
DRI TM Tricyclics Serum Tox Assay
K213875 · LFH
Microgenics Corporation
Toxicology · 373d
Cleared Dec 13, 2022
Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer...
K220046 · DJG
Shenzhen Superbio Technology Co., Ltd.
Toxicology · 342d
Cleared Nov 10, 2022
Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx
K222667 · NFT
Vivachek Biotech (Hangzhou) Co., Ltd.
Toxicology · 65d
Cleared Aug 30, 2022
Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM)...
K221871 · NFT
Healstone Biotech, Inc.
Toxicology · 63d
Cleared May 09, 2022
Immunalysis Tapentadol Urine HEIA
K203527 · DJG
Lmmunalysis Corporation
Toxicology · 523d
Cleared May 05, 2022
HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx
K220685 · NFT
Qingdao Hightop Biotech Co., Ltd.
Toxicology · 58d
Cleared Apr 18, 2022
Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair
K212952 · LCM
Psychemedics Corporation
Toxicology · 214d
Cleared Feb 18, 2022
Acetaminophen
K202644 · LDP
Sekisui Diagnostics P.E.I., Inc.
Toxicology · 525d
Cleared Jan 27, 2022
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay...
K213211 · DIO
Carolina Liquid Chemistries Corp.
Toxicology · 120d
Cleared Dec 22, 2021
SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay
K203564 · DJG
Immunalysis Corporation
Toxicology · 380d
Cleared Dec 22, 2021
SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay
K203647 · LAF
Immunalysis Corporation
Toxicology · 373d
Cleared Dec 21, 2021
iCOquit® Smokerlyzer®
K211918 · CCJ
Bedfont Scientific, Ltd.
Toxicology · 183d
Cleared Dec 15, 2021
Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair
K210212 · LAF
Psychemedics Corporation
Toxicology · 322d
Cleared Sep 24, 2021
DRI Cocaine Metabolite Assay
K211973 · DIO
Microgenics Corporation
Toxicology · 91d
Cleared Aug 13, 2021
VITROS Chemistry Products PHBR Slides
K210858 · DLZ
Ortho-Clinical Diagnostics, Inc.
Toxicology · 143d
Cleared Aug 12, 2021
AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
K201630 · DJG
Assure Tech. (Hangzhou) Co, Ltd.
Toxicology · 422d
Cleared Aug 12, 2021
First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First...
K210327 · QBF
W.H.P.M., Inc.
Toxicology · 189d
Cleared Aug 05, 2021
ARK Lacosamide Assay
K201089 · NWM
ARK Diagnostics, Inc.
Toxicology · 469d
Cleared Jul 27, 2021
Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair,...
K201326 · DJG
Psychemedics Corporation
Toxicology · 434d