FDA 510(k) Application Details - K063390

Device Classification Name	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)   More FDA Info for this Device
510(K) Number	K063390
Device Name	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Applicant	IND DIAGNOSTIC INC. P.O. BOX 162 ALTAMONTE SPRINGS, FL 32716 US Other 510(k) Applications for this Company
Contact	BRIAN LEMAY 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	11/09/2006
Decision Date	03/01/2007
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	Y
Expedited Review