Clearance Summary
Nova Allegro HbA1c Assay, Nova Allegro Analyzer received FDA 510(k) clearance under submission number K221326, sponsored by Nova Biomedical Corporation. The device was reviewed via the Dual Track premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2024-11-22.
- Submission: K221326
- Applicant / Sponsor: Nova Biomedical Corporation
- Clearance pathway: Dual Track
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7470
- Decision date: 2024-11-22
Classification & Regulation
This clearance is catalogued under FDA product code LCP and 21 CFR 864.7470, within the Hematology review panel as a Class II device.