FDA 510(k)

AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup

Numéro K : K261984 · 2026-07-17

Date de décision2026-07-17

Code produitNFT

Comité consultatifTX

DécisionSubstantially Equivalent

Résumé du dispositif

AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup is the device name listed in this FDA 510(k) record. The listed applicant is Assure Tech., LLC. It received FDA 510(k) clearance on 2026-07-17 under 510(k) number K261984. The device is classified under product code NFT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup?

AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup is a medical device that received FDA 510(k) clearance on 2026-07-17. The listed applicant is Assure Tech., LLC. The 510(k) number is K261984.

When did AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup receive FDA 510(k) clearance?

AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup received FDA 510(k) clearance on 2026-07-17, under 510(k) number K261984.

Who is the listed applicant for AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup?

The FDA 510(k) record lists Assure Tech., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup?

The FDA product code for AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup is NFT.

Essais cliniques associés

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Dispositifs connexes (Code : NFT)

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Source officielle

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