Cleared Traditional

Cystatin C

K242585 · SENTINEL CH. SpA · Chemistry
May 2025
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K242585 is an FDA 510(k) clearance for the Cystatin C, 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 review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K242585 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code NDY — Test, Cystatin C
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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