FDA 510(k) Application Details - K162754

Device Classification Name	System, Test, Vitamin D   More FDA Info for this Device
510(K) Number	K162754
Device Name	System, Test, Vitamin D
Applicant	NanoEnTek USA, Inc. 5627 Stoneridge Drive Suite 304 Pleasanton, CA 94588 US Other 510(k) Applications for this Company
Contact	Jimmy Chen 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	09/30/2016
Decision Date	01/12/2017
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