ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K112653
Device Name ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS
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 862.1660
Classification Product Code
JJX  
Subsequent Product Codes
CGA   NBW  
Date Received 09/12/2011
Decision Date 04/09/2012
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