510(k) K221326
K221326 is an FDA 510(k) premarket notification submitted by Nova Biomedical Corporation for the device "Nova Allegro HbA1c Assay, Nova Allegro Analyzer". The FDA issued a decision of Substantially Equivalent on November 22, 2024. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Nova Biomedical Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2024
- Date Received
- May 6, 2022
- Clearance Type
- Dual Track
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay, Glycosylated Hemoglobin
- Device Class
- Class II
- Regulation Number
- 864.7470
- Review Panel
- HE
- Submission Type