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FDA 510(k)

Labcorp Fentanyl Urine Visual Test

K-Number: K252684 · 2026-01-29

ApplicantMedtox Diagnostics, Inc.
Decision Date2026-01-29
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Labcorp Fentanyl Urine Visual Test 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 2026-01-29 under 510(k) number K252684. 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 Labcorp Fentanyl Urine Visual Test?

Labcorp Fentanyl Urine Visual Test is a medical device that received FDA 510(k) clearance on 2026-01-29. The listed applicant is Medtox Diagnostics, Inc.. The 510(k) number is K252684.

When did Labcorp Fentanyl Urine Visual Test receive FDA 510(k) clearance?

Labcorp Fentanyl Urine Visual Test received FDA 510(k) clearance on 2026-01-29, under 510(k) number K252684.

Who is the listed applicant for Labcorp Fentanyl Urine Visual Test?

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 Labcorp Fentanyl Urine Visual Test?

The FDA product code for Labcorp Fentanyl Urine Visual Test is DJG.

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.

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.K240124BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA ReaderVivachek Biotech (Hangzhou) Co., Ltd.

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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