FDA 510(k) Application Details - K141114

Device Classification Name	System, Test, Vitamin D   More FDA Info for this Device
510(K) Number	K141114
Device Name	System, Test, Vitamin D
Applicant	Bio-Rad Laboratories 5500 E. 2nd Street Benicia, CA 94510 US Other 510(k) Applications for this Company
Contact	Juang Wang 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	04/30/2014
Decision Date	01/09/2015
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