FDA 510(k) Application Details - K150396

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K150396
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	APEX BIOTECHNOLOGY CORP. NO. 7 LI-HSIN ROAD V, HSINCHU SCIENCE PARK HSINCHU 30078 CN Other 510(k) Applications for this Company
Contact	Hsue-mei Lee Other 510(k) Applications for this Contact
Regulation Number	862.1345   More FDA Info for this Regulation Number
Classification Product Code	NBW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/18/2015
Decision Date	10/14/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review