Source document or public record
FDA 510(k) K220085 — KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
FDA 510(k) index record K220085. Device: KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit. Applicant as listed: Kronus, Inc.. Decision date: 2023-08-24.
Source
"device_name": "KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit"
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 K220085.
Device name: KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit. Applicant as listed: Kronus, Inc..
Decision date: 2023-08-24. Decision wording: Substantially Equivalent.
Product code: OIF. 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.