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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name breast milk macronutrients test system
De Novo Number DEN180007
Device Name Miris Human Milk Analyzer
Requester
miris ab
kungsgatan 115
uppsala,  SE 753 18
Contact elin hallen
Regulation Number862.1493
Classification Product Code
QEI  
Date Received02/12/2018
Decision Date 12/21/2018
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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