Cystatin C
FDA 510(k) clearance K242585 · decided 2025-05-16
Clearance details
- K-number
- K242585
- Device name
- Cystatin C
- Applicant
- SENTINEL CH. SpA
- Decision
- Substantially Equivalent
- Date received
- 2024-08-30
- Decision date
- 2025-05-16
- Days to decision
- 259 days
- Clearance type
- Traditional
- Product code
- NDY
- Device class
- 2
- Regulation number
- 862.1225
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Milan (Mi), IT
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.