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FDA 510(k)

BinaxNOW COVID-19 Ag Card

K-Number: K250273 · 2025-06-13

ApplicantAbbott Diagnostics Scarborough, Inc.
Decision Date2025-06-13
Product CodeQVF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BinaxNOW COVID-19 Ag Card is a medical device manufactured by Abbott Diagnostics Scarborough, Inc.. It received FDA 510(k) clearance on 2025-06-13 under approval number K250273. The device is classified under product code QVF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BinaxNOW COVID-19 Ag Card?

BinaxNOW COVID-19 Ag Card is a medical device that received FDA 510(k) clearance on 2025-06-13. It is manufactured by Abbott Diagnostics Scarborough, Inc.. The 510(k) number is K250273.

When was BinaxNOW COVID-19 Ag Card approved by the FDA?

BinaxNOW COVID-19 Ag Card received FDA 510(k) clearance on 2025-06-13, under approval number K250273.

What company makes BinaxNOW COVID-19 Ag Card?

BinaxNOW COVID-19 Ag Card is manufactured by Abbott Diagnostics Scarborough, Inc..

What is the FDA product code for BinaxNOW COVID-19 Ag Card?

The FDA product code for BinaxNOW COVID-19 Ag Card is QVF.

Other Devices by Abbott Diagnostics Scarborough, 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.

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