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)
510(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
TypeDirect
Date Received2018-02-12
Decision Date2018-12-21
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
27350107530076 DEN180007 000
07350107530027 DEN180007 000
07350107530034 DEN180007 000
07350107530027 DEN180007 000
07350107530034 DEN180007 000
07350107530027 DEN180007 000
07350107530034 DEN180007 000
07350107530027 DEN180007 000
07350107530034 DEN180007 000
07350107530027 DEN180007 000
07350107530034 DEN180007 000
07350107530027 DEN180007 000
07350107530034 DEN180007 000
07350107530027 DEN180007 000
07350107530034 DEN180007 000
07350107530034 DEN180007 000
07350107530027 DEN180007 000
07350107530034 DEN180007 000
07350107530034 DEN180007 000
07350107530027 DEN180007 000
07350107530034 DEN180007 000
07350107530027 DEN180007 000
07350107530034 DEN180007 000
07350107530027 DEN180007 000
07350107530034 DEN180007 000
07350107530027 DEN180007 000
07350107530034 DEN180007 000
07350107530027 DEN180007 000
07350107530034 DEN180007 000
07350107530027 DEN180007 000
07350107530034 DEN180007 000
07350107530027 DEN180007 000
07350107530027 DEN180007 000

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