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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Breast Milk Macronutrients Test System
510(k) Number K223085
Device Name Miris Human Milk Analyzer (HMA)
Applicant
Miris AB
Danmarksgatan 26
Uppsala,  SE 75323
Applicant Contact Elin Hallen
Correspondent
Hogan Lovell US LLP
555 13th St., NW
Washington,  DC  20004
Correspondent Contact John J Smith
Classification Product Code
QEI  
Date Received09/30/2022
Decision Date 09/29/2023
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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