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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, hemoglobin, automated
510(k) Number K122553
Device Name MISSION PLUS HB HEMOGLOBIN TESTING 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
Correspondent Contact QIYI XIE
Regulation Number864.5620
Classification Product Code
GKR  
Subsequent Product Code
GGM  
Date Received08/21/2012
Decision Date 08/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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