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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Esterase--Oxidase, Cholesterol
510(k) Number K132031
Device Name AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL
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 Number862.1175
Classification Product Code
CHH  
Subsequent Product Codes
JGY   JJY   LBR  
Date Received07/18/2013
Decision Date 03/21/2014
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
Predetermined Change
Control Plan Authorized		 No
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