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. Device class: 2.

Clearance details

Applicant: SENTINEL CH. SpA
Product code: Code NDY
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 2024-08-30
Decision date: 2025-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milan (Mi), IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code NDY

K181082 — ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)2018-05-25
K171072 — N Latex Cystatin C; N Protein Standard UY2017-05-12
K161817 — Tina-quant Cystatin C Gen.22016-07-27
K141143 — COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET2014-07-17
K111664 — DIAZYME CYSTATIN C POC TEST KIT2012-03-30

More clearances from SENTINEL CH. SpA

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