FDA 510(k) Application Details - K081703

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K081703
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	ENTRA HEALTH SYSTEMS, LTD. 7833 KNOLLBROOK DRIVE PLEASANTON, CA 94588 US Other 510(k) Applications for this Company
Contact	CARLOS GONZALEZ 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	06/17/2008
Decision Date	01/08/2009
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