BinaxNOW COVID-19 Antigen Self Test
K-Number: K243518 · 2025-02-11
ApplicantAbbott Diagnostics Scarborough, Inc.
Decision Date2025-02-11
Product CodeQYT
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
BinaxNOW COVID-19 Antigen Self Test is a medical device manufactured by Abbott Diagnostics Scarborough, Inc.. It received FDA 510(k) clearance on 2025-02-11 under approval number K243518. 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 BinaxNOW COVID-19 Antigen Self Test?
BinaxNOW COVID-19 Antigen Self Test is a medical device that received FDA 510(k) clearance on 2025-02-11. It is manufactured by Abbott Diagnostics Scarborough, Inc.. The 510(k) number is K243518.
When was BinaxNOW COVID-19 Antigen Self Test approved by the FDA?
BinaxNOW COVID-19 Antigen Self Test received FDA 510(k) clearance on 2025-02-11, under approval number K243518.
What company makes BinaxNOW COVID-19 Antigen Self Test?
BinaxNOW COVID-19 Antigen Self Test is manufactured by Abbott Diagnostics Scarborough, Inc..
What is the FDA product code for BinaxNOW COVID-19 Antigen Self Test?
The FDA product code for BinaxNOW COVID-19 Antigen Self Test is QYT.
Other Devices by Abbott Diagnostics Scarborough, Inc.
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K233842iHealth COVID-19 Antigen Rapid TestIhealth Labs, Inc.
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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.