Source document or public record
FDA 510(k) K221326 — Nova Allegro HbA1c Assay, Nova Allegro Analyzer
FDA 510(k) index record K221326. Device: Nova Allegro HbA1c Assay, Nova Allegro Analyzer. Applicant as listed: Nova Biomedical Corporation. Decision date: 2024-11-22.
Source
"device_name": "Nova Allegro HbA1c Assay, Nova Allegro Analyzer"
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 K221326.
Device name: Nova Allegro HbA1c Assay, Nova Allegro Analyzer. Applicant as listed: Nova Biomedical Corporation.
Decision date: 2024-11-22. Decision wording: Substantially Equivalent.
Product code: LCP. Regulation: 21 CFR 864.7470. Medical specialty: Hematology.
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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