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FDA 510(k)

OHC COVID-19 Antigen Self Test

K-Number: K241313 · 2025-05-30

ApplicantOsang, LLC
Decision Date2025-05-30
Product CodeQYT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

OHC COVID-19 Antigen Self Test is the device name listed in this FDA 510(k) record. The listed applicant is Osang, LLC. It received FDA 510(k) clearance on 2025-05-30 under 510(k) number K241313. The device is classified under product code QYT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OHC COVID-19 Antigen Self Test?

OHC COVID-19 Antigen Self Test is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Osang, LLC. The 510(k) number is K241313.

When did OHC COVID-19 Antigen Self Test receive FDA 510(k) clearance?

OHC COVID-19 Antigen Self Test received FDA 510(k) clearance on 2025-05-30, under 510(k) number K241313.

Who is the listed applicant for OHC COVID-19 Antigen Self Test?

The FDA 510(k) record lists Osang, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OHC COVID-19 Antigen Self Test?

The FDA product code for OHC COVID-19 Antigen Self Test is QYT.

Other records listing Osang, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243262QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test

Related Devices (Code: QYT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260754Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen TestAssure Tech., LLCK260095Heal-Check Rapid COVID-19 Antigen Self-TestHealgen Scientific,, LLCK251916GenBody COVID-19 Ag Home TestGenbody.Inc.K251595COVID-19 Detect Rapid Self -TestInBios International, Inc.K251753GenaCheck COVID-19 Rapid Self-TestGenabio Diagnostics, Inc.K243518BinaxNOW™ COVID-19 Antigen Self TestAbbott Diagnostics Scarborough, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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