Cystatin C— 510(k) K242585

Substantially Equivalent

SENTINEL CH. SpA

FDA 510(k) clearance K242585 for Cystatin C, Substantially Equivalent on 2025-05-16. Applicant: SENTINEL CH. SpA.

Clearance details

Applicant: SENTINEL CH. SpA
Product code: Code NDY
Advisory panel: Clinical Chemistry
Date received: 2024-08-30
Decision date: 2025-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milan (Mi), IT

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