FDA 510(k) Application Details - K133410

Device Classification Name	System, Test, Vitamin D   More FDA Info for this Device
510(K) Number	K133410
Device Name	System, Test, Vitamin D
Applicant	DIAZYME LABORATORIES 12889 GREGG COURT POWAY, CA 92064 US Other 510(k) Applications for this Company
Contact	Abhijit Datta 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	11/07/2013
Decision Date	03/14/2014
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