K252206 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 January 9, 2026, 179 days after receiving the submission on July 14, 2025.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K252206 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 2025 |
| Decision Date | January 09, 2026 |
| Days to Decision | 179 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 |