DeviceClearance

Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test— 510(k) K260754

Substantially Equivalent

Assure Tech., LLC

FDA 510(k) clearance K260754 for Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test, Substantially Equivalent on 2026-06-05. Applicant: Assure Tech., LLC.

Clearance details

Applicant
Assure Tech., LLC
Product code
Code QYT
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Wilmington, DE, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.