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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 K151809
Device Name Alere Afinion HbA1c, Alere Afinion AS100 Analyzer
Applicant
Alere Technologies AS
Kjelsaasveien 161
Oslo,  NO NO-0884
Applicant Contact Kari Skinnemoen
Correspondent
Alere Technologies AS
Kjelsaasveien 161
Oslo,  NO NO-0884
Correspondent Contact Kari Skinnemoen
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Code
JQT  
Date Received07/02/2015
Decision Date 09/25/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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