FDA 510(k) Application Details - K242585

Device Classification Name	Test, Cystatin C   More FDA Info for this Device
510(K) Number	K242585
Device Name	Test, Cystatin C
Applicant	Sentinel CH. S.p.A. Via Robert Koch, 2 Milan (MI) 20152 IT Other 510(k) Applications for this Company
Contact	Patricia DupΘ Other 510(k) Applications for this Contact
Regulation Number	862.1225   More FDA Info for this Regulation Number
Classification Product Code	NDY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/30/2024
Decision Date	05/16/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review