Source document or public record
FDA 510(k) K243518 — BinaxNOW COVID-19 Antigen Self Test
FDA 510(k) index record K243518. Device: BinaxNOW COVID-19 Antigen Self Test. Applicant as listed: Abbott Diagnostics Scarborough, Inc.. Decision date: 2025-02-11.
Source
"device_name": "BinaxNOW COVID-19 Antigen Self Test"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K243518.
Device name: BinaxNOW COVID-19 Antigen Self Test. Applicant as listed: Abbott Diagnostics Scarborough, Inc..
Decision date: 2025-02-11. Decision wording: Substantially Equivalent.
Product code: QYT. Regulation: 21 CFR 866.3984. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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