K242585 is an FDA 510(k) clearance for the Cystatin C. This device is classified as a Test, Cystatin C (Class II - Special Controls, product code NDY).
Submitted by SENTINEL CH. SpA (Milan (Mi), IT). The FDA issued a Cleared decision on May 16, 2025, 259 days after receiving the submission on August 30, 2024.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K242585 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2024 |
| Decision Date | May 16, 2025 |
| Days to Decision | 259 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NDY - Test, Cystatin C |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1225 |