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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Low Density, Lipoprotein
510(k) Number K210801
Device Name AXINON® LDL-p Test System
Applicant
Numares AG
Am Biopark 9
Regensburg,  DE 93053
Applicant Contact Stefanie Dukorn
Correspondent
Numares AG
Am Biopark 9
Regensburg,  DE 93053
Correspondent Contact Stefanie Dukorn
Regulation Number862.1475
Classification Product Code
MRR  
Date Received03/17/2021
Decision Date 07/19/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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