OHC COVID-19 Antigen Self Test— 510(k) K241313

Substantially Equivalent

Osang, LLC

FDA 510(k) clearance K241313 for OHC COVID-19 Antigen Self Test, Substantially Equivalent on 2025-05-30. Applicant: Osang, LLC. Device class: 2.

Clearance details

Applicant: Osang, LLC
Product code: Code QYT
Device class: Class 2
Regulation: 21 CFR 866.3984
Advisory panel: Microbiology
Date received: 2024-05-09
Decision date: 2025-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pasadena, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QYT

K260754 — Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test2026-06-05
K260095 — Heal-Check Rapid COVID-19 Antigen Self-Test2026-04-13
K251916 — GenBody COVID-19 Ag Home Test2026-03-13
K251595 — COVID-19 Detect Rapid Self -Test2025-10-12
K251753 — GenaCheck COVID-19 Rapid Self-Test2025-09-05

More clearances from Osang, LLC

K243262 — QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test2025-01-13

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