K221326 is an FDA 510(k) clearance for the Nova Allegro HbA1c Assay, Nova Allegro Analyzer. This device is classified as a Assay, Glycosylated Hemoglobin (Class II - Special Controls, product code LCP).
Submitted by Nova Biomedical Corporation (Walham, US). The FDA issued a Cleared decision on November 22, 2024, 931 days after receiving the submission on May 6, 2022.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.7470.
| 510(k) Number | K221326 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2022 |
| Decision Date | November 22, 2024 |
| Days to Decision | 931 days |
| Submission Type | Dual Track |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LCP — Assay, Glycosylated Hemoglobin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7470 |