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FDA 510(k)

PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM

K-Number: K091454 · 2009-07-24

ApplicantMedtox Diagnostics, Inc.
Decision Date2009-07-24
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM 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 2009-07-24 under 510(k) number K091454. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM?

PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2009-07-24. The listed applicant is Medtox Diagnostics, Inc.. The 510(k) number is K091454.

When did PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM receive FDA 510(k) clearance?

PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM received FDA 510(k) clearance on 2009-07-24, under 510(k) number K091454.

Who is the listed applicant for PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM?

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 PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM?

The FDA product code for PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM is DJG.

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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 SYSTEMK080635MEDTOXSCANK060351MEDTOX OXYCODONEK050394SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS

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Related Devices (Code: DJG)

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 TestMedtox Diagnostics, Inc.K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories LimitedK253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis CorporationK251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)Healgen Scientific,, LLCK251634LZI Fentanyl III Enzyme ImmunoassayLin-Zhi International, 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.

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