FDA 510(k) Application Details - K141463

Device Classification Name	System, Test, Vitamin D   More FDA Info for this Device
510(K) Number	K141463
Device Name	System, Test, Vitamin D
Applicant	DiaSorin Inc. 1951 NORTHWESTERN AVENUE STILLWATER, MN 55082-0285 US Other 510(k) Applications for this Company
Contact	CAROL A DEPOUW 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	06/03/2014
Decision Date	12/10/2014
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