Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MEDTOXSCAN

K-Number: K080635 · 2009-02-13

ApplicantMedtox Diagnostics, Inc.
Decision Date2009-02-13
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MEDTOXSCAN is the device name listed in this FDA 510(k) record. The listed applicant is Medtox Diagnostics, Inc.. It received FDA 510(k) clearance on 2009-02-13 under 510(k) number K080635. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDTOXSCAN?

MEDTOXSCAN is a medical device that received FDA 510(k) clearance on 2009-02-13. The listed applicant is Medtox Diagnostics, Inc.. The 510(k) number is K080635.

When did MEDTOXSCAN receive FDA 510(k) clearance?

MEDTOXSCAN received FDA 510(k) clearance on 2009-02-13, under 510(k) number K080635.

Who is the listed applicant for MEDTOXSCAN?

The FDA 510(k) record lists Medtox Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDTOXSCAN?

The FDA product code for MEDTOXSCAN is DKZ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medtox Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252684Labcorp Fentanyl Urine Visual TestK100951MEDTOX BUPRENORPHINE TESTK100023PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEMK091454PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEMK060351MEDTOX OXYCODONEK050394SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS

View all 22 devices →

Related Devices (Code: DKZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240670DRI Ecstasy Plus AssayMicrogenics CorporationK233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxHangzhou AllTest Biotech Co., Ltd.K231137Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science Co., Ltd.K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc.K191099Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test PanelAtlas MedicalK182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑