FDA 510(k) Application Details - K052525

Device Classification Name	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)   More FDA Info for this Device
510(K) Number	K052525
Device Name	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Applicant	D.F.I. CO LTD 2815 MCGAW AVENUE IRVINE, CA 92614 US Other 510(k) Applications for this Company
Contact	ASAD R ZAIDI Other 510(k) Applications for this Contact
Regulation Number	862.1340   More FDA Info for this Regulation Number
Classification Product Code	JIL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/14/2005
Decision Date	03/29/2006
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