ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM


Device Classification Name

glucose oxidase, glucose

510(k) Number K111371
Device Name ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM
Applicant
ACON LABORATORIES, INC.
10125 mesa rim rd.
san diego, 
CA 
92121

Applicant Contact qiyi xie
Correspondent
ACON LABORATORIES, INC.
10125 mesa rim rd.
san diego, 
CA 
92121

Correspodent Contact qiyi xie
Regulation Number 862.1345
Classification Product Code
CGA  
Subsequent Product Codes
JJX   NBW  
Date Received 05/16/2011
Decision Date 10/06/2011
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