FDA 510(k)

Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test

Numéro K : K260754 · 2026-06-05

Date de décision2026-06-05

Code produitQYT

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test 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 2026-06-05 under 510(k) number K260754. The device is classified under product code QYT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test?

Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test is a medical device that received FDA 510(k) clearance on 2026-06-05. The listed applicant is Assure Tech., LLC. The 510(k) number is K260754.

When did Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test receive FDA 510(k) clearance?

Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test received FDA 510(k) clearance on 2026-06-05, under 510(k) number K260754.

Who is the listed applicant for Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test?

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 Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test?

The FDA product code for Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test is QYT.

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Dispositifs connexes (Code : QYT)

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Source officielle

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