FDA 510(k) Application Details - K100806

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K100806
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	DELBIO INCORPORATION 3F, NO. 252, SHANGYING ROAD GUISHAN INDUSTRIAL ZONE TAOYUAN COUNTY 33341 TW Other 510(k) Applications for this Company
Contact	NICKY PAN 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	03/22/2010
Decision Date	09/16/2011
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