K242585
- 510(k) number
- K242585
- Device name
- Cystatin C
- Applicant
- SENTINEL CH. SpA IT
- Product code
- NDY — Test, Cystatin C
- Decision date
- 2025-05-16
- Date received
- 2024-08-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
510(k) Summary (official FDA PDF): K242585.pdf
Official FDA record: K242585
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.