ARK CARE DIABETES MANAGMENT SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K110709
Device Name ARK CARE DIABETES MANAGMENT SYSTEM
Applicant
ARKRAY Factory USA, Inc.
5182 west 76th st.
minneapolis, 
MN 
55439

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

Correspodent Contact tyler foutch
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JQP  
Date Received 03/14/2011
Decision Date 05/19/2011
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