CareSuperb COVID-19 Antigen Home Test
K-Number: K241915 · 2025-01-29
ApplicantAccess Bio, Inc.
Decision Date2025-01-29
Product CodeQYT
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
CareSuperb COVID-19 Antigen Home Test is a medical device manufactured by Access Bio, Inc.. It received FDA 510(k) clearance on 2025-01-29 under approval number K241915. 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 CareSuperb COVID-19 Antigen Home Test?
CareSuperb COVID-19 Antigen Home Test is a medical device that received FDA 510(k) clearance on 2025-01-29. It is manufactured by Access Bio, Inc.. The 510(k) number is K241915.
When was CareSuperb COVID-19 Antigen Home Test approved by the FDA?
CareSuperb COVID-19 Antigen Home Test received FDA 510(k) clearance on 2025-01-29, under approval number K241915.
What company makes CareSuperb COVID-19 Antigen Home Test?
CareSuperb COVID-19 Antigen Home Test is manufactured by Access Bio, Inc..
What is the FDA product code for CareSuperb COVID-19 Antigen Home Test?
The FDA product code for CareSuperb COVID-19 Antigen Home Test is QYT.
Other Devices by Access Bio, Inc.
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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.