Source document or public record
FDA 510(k) K221925 — ID NOW COVID-19 2.0
FDA 510(k) index record K221925. Device: ID NOW COVID-19 2.0. Applicant as listed: Abbott Diagnostics Scarborough, Inc.. Decision date: 2023-08-10.
Source
"device_name": "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 K221925.
Device name: ID NOW COVID-19 2.0. Applicant as listed: Abbott Diagnostics Scarborough, Inc..
Decision date: 2023-08-10. Decision wording: Substantially Equivalent.
Product code: QWR. 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.
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