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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, blood glucose, over the counter
510(k) Number K123010
Device Name ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM
Applicant
ACON LABORATORIES, INC.
10125 MESA RIM ROAD
SAN DIEGO,  CA  92121
Applicant Contact Xie Qiyi
Correspondent
ACON LABORATORIES, INC.
10125 MESA RIM ROAD
SAN DIEGO,  CA  92121
Correspondent Contact Xie Qiyi
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received09/27/2012
Decision Date 12/14/2012
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
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