Source document or public record
FDA 510(k) K243979 — Aptiva APS IgA Reagent
FDA 510(k) index record K243979. Device: Aptiva APS IgA Reagent. Applicant as listed: Inova Diagnostics, Inc.. Decision date: 2026-02-06.
Source
"device_name": "Aptiva APS IgA Reagent"
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 K243979.
Device name: Aptiva APS IgA Reagent. Applicant as listed: Inova Diagnostics, Inc..
Decision date: 2026-02-06. Decision wording: Substantially Equivalent.
Product code: MSV. Regulation: 21 CFR 866.5660. Medical specialty: Immunology.
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.