K221813 is an FDA 510(k) clearance for the Nova Allegro UACR Assay, Nova Allegro Analyzer. This device is classified as a Alkaline Picrate, Colorimetry, Creatinine (Class II - Special Controls, product code CGX).
Submitted by Nova Biomedical Corporation (Walham, US). The FDA issued a Cleared decision on November 19, 2024, 881 days after receiving the submission on June 22, 2022.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K221813 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2022 |
| Decision Date | November 19, 2024 |
| Days to Decision | 881 days |
| Submission Type | Dual Track |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGX — Alkaline Picrate, Colorimetry, Creatinine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1225 |