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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 a medical device manufactured by Medtox Diagnostics, Inc.. It received FDA 510(k) clearance on 2026-01-29 under approval 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. It is manufactured by Medtox Diagnostics, Inc.. The 510(k) number is K252684.

When was Labcorp Fentanyl Urine Visual Test approved by the FDA?

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

What company makes Labcorp Fentanyl Urine Visual Test?

Labcorp Fentanyl Urine Visual Test is manufactured by Medtox Diagnostics, Inc..

What is the FDA product code for Labcorp Fentanyl Urine Visual Test?

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

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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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