FDA 510(k) Application Details - K053312

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K053312
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	BIOPTIK TECHNOLOGY, INC. 6833 ST. LAWRENCE STREET PLANO, TX 75024 US Other 510(k) Applications for this Company
Contact	ERIC LUO 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	11/28/2005
Decision Date	03/01/2006
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