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)

VERDICT -II TCA, VERDICT-II MTD

K-Number: K011545 · 2001-06-08

ApplicantMedtox Diagnostics, Inc.
Decision Date2001-06-08
Product CodeLFG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VERDICT -II TCA, VERDICT-II MTD 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 2001-06-08 under 510(k) number K011545. The device is classified under product code LFG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERDICT -II TCA, VERDICT-II MTD?

VERDICT -II TCA, VERDICT-II MTD is a medical device that received FDA 510(k) clearance on 2001-06-08. The listed applicant is Medtox Diagnostics, Inc.. The 510(k) number is K011545.

When did VERDICT -II TCA, VERDICT-II MTD receive FDA 510(k) clearance?

VERDICT -II TCA, VERDICT-II MTD received FDA 510(k) clearance on 2001-06-08, under 510(k) number K011545.

Who is the listed applicant for VERDICT -II TCA, VERDICT-II MTD?

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 VERDICT -II TCA, VERDICT-II MTD?

The FDA product code for VERDICT -II TCA, VERDICT-II MTD is LFG.

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 SYSTEMK080635MEDTOXSCANK060351MEDTOX OXYCODONE

View all 22 devices →

Related Devices (Code: LFG)

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.

K112395WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TESTGuangzhou Wondfo Biotech Co., Ltd.K072062UCP MULTIPLE DRUG SCREEN TEST CUPSUcp Biosciences, Inc.K061457UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTSUcp Biosciences, Inc.K021526ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICEACON Laboratories, Inc.K980249ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCAPrinceton BioMeditech Corp.K870823EMIT NORTRIPTYLINE ASSAYSyva Co.

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.

↑