Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test— 510(k) K260754
Substantially EquivalentAssure 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. Device class: 2.
Clearance details
- Applicant
- Assure Tech., LLC
- Product code
- Code QYT
- Device class
- Class 2
- Regulation
- 21 CFR 866.3984
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wilmington, DE, US
Recent devices under product code QYT
view allMore clearances from Assure Tech., LLC
view all- K261984 — AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup
- K252259 — AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup
- K250117 — FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
- K243996 — AssureTech Panel Dip Tests +3 more
- K243573 — FaStep Early Pregnancy Rapid Test Strip +2 more
Data sourced from openFDA. This site is unofficial and independent of the FDA.