K221326
- 510(k) number
- K221326
- Device name
- Nova Allegro HbA1c Assay, Nova Allegro Analyzer
- Applicant
- Nova Biomedical Corporation MA · US
- Product code
- LCP — Assay, Glycosylated Hemoglobin
- Decision date
- 2024-11-22
- Date received
- 2022-05-06
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K221326.pdf
Official FDA record: K221326
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.