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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Cystatin C
510(k) Number K242585
Device Name Cystatin C
Applicant
SENTINEL CH. SpA
Via Robert Koch, 2
Milan (Mi),  IT 20152
Applicant Contact Patricia Dupé
Correspondent
SENTINEL CH. SpA
Via Robert Koch, 2
Milan (Mi),  IT 20152
Correspondent Contact Patricia Dupé
Regulation Number862.1225
Classification Product Code
NDY  
Date Received08/30/2024
Decision Date 05/16/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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