Source document or public record
FDA 510(k) K250273 — BinaxNOW COVID-19 Ag Card
FDA 510(k) index record K250273. Device: BinaxNOW COVID-19 Ag Card. Applicant as listed: Abbott Diagnostics Scarborough, Inc.. Decision date: 2025-06-13.
Source
"device_name": "BinaxNOW COVID-19 Ag Card"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K250273.
Device name: BinaxNOW COVID-19 Ag Card. Applicant as listed: Abbott Diagnostics Scarborough, Inc..
Decision date: 2025-06-13. Decision wording: Substantially Equivalent.
Product code: QVF. Regulation: 21 CFR 866.3982. 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.
Interested in these solutions?
Submit a sourcing request with the assays, volumes, and timeline of your own project.