Miris Human Milk Analyzer

Breast Milk Macronutrients Test System

Miris AB

The following data is part of a De Novo classification by Miris Ab with the FDA for Miris Human Milk Analyzer.

Pre-market Notification Details

DeNovo IDDEN180007
Device Name:Miris Human Milk Analyzer
ClassificationBreast Milk Macronutrients Test System
Applicant Miris AB kungsgatan 115 Uppsala,  SE 753 18
ContactElin Hallen
Product CodeQEI  
CFR Regulation Number862.1493 [🔎]
DecisionGranted (DENG)
501(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardClinical Chemistry
Classification AdvisoryClinical Chemistry
Date Received2018-02-12
Decision Date2018-12-21
Reclassification Order:Reclassification Order


Device IdentifiersubmissionNumberSupplement
27350107530076 DEN180007 000
07350107530034 DEN180007 000
07350107530027 DEN180007 000

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