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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 K110056
Device Name AFINION ANALYZER
Applicant
Axis-Shield Poc AS
P.O. Box 6863
Rodelokka
Oslo,  NO N-0504
Applicant Contact KARI SKINNEMOEN
Correspondent
Axis-Shield Poc AS
P.O. Box 6863
Rodelokka
Oslo,  NO N-0504
Correspondent Contact KARI SKINNEMOEN
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Codes
DCK   JFY   JIR   JJX   JJY  
JQT  
Date Received01/10/2011
Decision Date 02/15/2011
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
Predetermined Change
Control Plan Authorized		 No
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