EXPRESS BLOOD GLUCOSE MONITORING SYSTEM


Device Classification Name

glucose oxidase, glucose

510(k) Number K024347
Device Name EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
Original Applicant
HYPOGUARD USA, INC.
5182 west 76th st.
minneapolis, 
MN 
55439

Original Contact bruce a macfarlane
Regulation Number 862.1345
Classification Product Code
CGA  
Subsequent Product Code
NBW  
Date Received 12/30/2002
Decision Date 03/28/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No