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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name assay, glycosylated hemoglobin
510(k) Number K130014
Device Name A1C GEAR SYSTEM
Applicant
Sakae Corporation
575 Shirlynn Court
Los Altos,  CA  94022
Applicant Contact ERICA B AMMIRATI
Correspondent
Sakae Corporation
575 Shirlynn Court
Los Altos,  CA  94022
Correspondent Contact ERICA B AMMIRATI
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Code
JJE  
Date Received01/02/2013
Decision Date 04/04/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
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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