Source document or public record
FDA 510(k) K260754 — Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test
FDA 510(k) index record K260754. Device: Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test. Applicant as listed: Assure Tech., LLC. Decision date: 2026-06-05.
Source
"device_name": "Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K260754.
Device name: Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test. Applicant as listed: Assure Tech., LLC.
Decision date: 2026-06-05. Decision wording: Substantially Equivalent.
Product code: QYT. Regulation: 21 CFR 866.3984. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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