FDA 510(k) Application Details - K210901

Device Classification Name	System, Test, Vitamin D   More FDA Info for this Device
510(K) Number	K210901
Device Name	System, Test, Vitamin D
Applicant	Roche Diagnostics 9115 Hague Road PO Box 50416 Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	Jamie Ferguson Other 510(k) Applications for this Contact
Regulation Number	862.1825   More FDA Info for this Regulation Number
Classification Product Code	MRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/2021
Decision Date	09/01/2021
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