ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM


Device Classification Name

glucose oxidase, glucose

510(k) Number K122110
Device Name ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM
Applicant
ACON LABORATORIES, INC.
10125 mesa rim road
san diego, 
CA 
92121

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

Correspodent Contact qiyi xie
Regulation Number 862.1345
Classification Product Code
CGA  
Subsequent Product Code
NBW  
Date Received 07/17/2012
Decision Date 11/21/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No