FDA 510(k) Application Details - K211058

Device Classification Name	Lipoprotein, Low-Density, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K211058
Device Name	Lipoprotein, Low-Density, Antigen, Antiserum, Control
Applicant	Sentinel CH. SpA Via Robert Koch 2 Milan 20152 IT Other 510(k) Applications for this Company
Contact	Patricia DupΘ Other 510(k) Applications for this Contact
Regulation Number	866.5600   More FDA Info for this Regulation Number
Classification Product Code	DFC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/09/2021
Decision Date	12/22/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review