FDA 510(k) Application Details - K241220

Device Classification Name	Lipoprotein, Low-Density, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K241220
Device Name	Lipoprotein, Low-Density, Antigen, Antiserum, Control
Applicant	Roche Diagnostics Operations 9115 Hague Road Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	Leslie Patterson 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	05/01/2024
Decision Date	01/24/2025
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