FDA 510(k) Application Details - K172992

Device Classification Name	System, Test, Vitamin D   More FDA Info for this Device
510(K) Number	K172992
Device Name	System, Test, Vitamin D
Applicant	Diazyme Laboratories 12889 Gregg Court Poway, CA 92130 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	09/27/2017
Decision Date	01/11/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review