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FDA 510(k)

VERDICT II, PROFILE II

K-Number: K031032 · 2003-07-14

ApplicantMedtox Diagnostics, Inc.
Decision Date2003-07-14
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VERDICT II, PROFILE II 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 2003-07-14 under 510(k) number K031032. 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 VERDICT II, PROFILE II?

VERDICT II, PROFILE II is a medical device that received FDA 510(k) clearance on 2003-07-14. The listed applicant is Medtox Diagnostics, Inc.. The 510(k) number is K031032.

When did VERDICT II, PROFILE II receive FDA 510(k) clearance?

VERDICT II, PROFILE II received FDA 510(k) clearance on 2003-07-14, under 510(k) number K031032.

Who is the listed applicant for VERDICT II, PROFILE II?

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, PROFILE II?

The FDA product code for VERDICT II, PROFILE II is DJG.

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Other records listing Medtox Diagnostics, Inc. as applicant

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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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