Source document or public record
FDA 510(k) K201956 — Zeus IFA ANA HEp-2 Test System, Zeus dIFine
FDA 510(k) index record K201956. Device: Zeus IFA ANA HEp-2 Test System, Zeus dIFine. Applicant as listed: Zeus Scientific, Inc.. Decision date: 2022-04-29.
Source
"device_name": "Zeus IFA ANA HEp-2 Test System, Zeus dIFine"
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 K201956.
Device name: Zeus IFA ANA HEp-2 Test System, Zeus dIFine. Applicant as listed: Zeus Scientific, Inc..
Decision date: 2022-04-29. Decision wording: Substantially Equivalent.
Product code: DHN. Regulation: 21 CFR 866.5100. 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.