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510(k) K260754

Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test by Assure Tech., LLC — Product Code QYT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2026
Date Received
March 9, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Over-The-Counter Covid-19 Antigen Test
Device Class
Class II
Regulation Number
866.3984
Review Panel
MI
Submission Type

For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.

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