FDA 510(k) Application Details - K010973

Device Classification Name	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)   More FDA Info for this Device
510(K) Number	K010973
Device Name	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Applicant	HYPOGUARD USA, INC. 5182 WEST 76TH ST. MINNEAPOLIS, MN 55439 US Other 510(k) Applications for this Company
Contact	BRUCE MACFARLANE 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	04/02/2001
Decision Date	09/11/2001
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