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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact QIYI XIE
Regulation Number862.1660
Classification Product Code
JJX  
Subsequent Product Codes
CGA   NBW  
Date Received09/12/2011
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
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