Source document or public record
FDA 510(k) K262747 — ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0
FDA 510(k) index record K262747. Device: ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0. Applicant as listed: Abbott Diagnostics Scarborough, Inc.. Decision date: 2026-08-31.
Source
"device_name": "ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0"
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 K262747.
Device name: ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0. Applicant as listed: Abbott Diagnostics Scarborough, Inc..
Decision date: 2026-08-31. Decision wording: Substantially Equivalent.
Product code: OCC. Regulation: 21 CFR 866.3980. 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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