ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM


Device Classification Name

glucose oxidase, glucose

510(k) Number K073416
Device Name ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM
Applicant
ARKRAY Factory USA, Inc.
5182 west 76th st.
minneapolis, 
MN 
55439

Applicant Contact tom speikers
Correspondent
ARKRAY Factory USA, Inc.
5182 west 76th st.
minneapolis, 
MN 
55439

Correspodent Contact tom speikers
Regulation Number 862.1345
Classification Product Code
CGA  
Subsequent Product Codes
JJX   NBW  
Date Received 12/03/2007
Decision Date 06/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No