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 a medical device manufactured by Osang, LLC. It received FDA 510(k) clearance on 2025-05-30 under approval 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. It is manufactured by Osang, LLC. The 510(k) number is K241313.
When was OHC COVID-19 Antigen Self Test approved by the FDA?
OHC COVID-19 Antigen Self Test received FDA 510(k) clearance on 2025-05-30, under approval number K241313.
What company makes OHC COVID-19 Antigen Self Test?
OHC COVID-19 Antigen Self Test is manufactured by Osang, LLC.
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 Devices by Osang, LLC
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K240728CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag TestCorDx, Inc.
K233842iHealth COVID-19 Antigen Rapid TestIhealth Labs, Inc.
K233373Flowflex® Plus COVID-19 Home TestACON Laboratories, Inc.
K231795QuickVue COVID-19 TestQuidel Corporation
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.