PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM

Severe Combined Immunodeficiency Disorder (scid) Newborn Screening Test System

WALLAC OY

The following data is part of a De Novo classification by Wallac Oy with the FDA for Perkinelmer Enlite Neonatal Trec Test System.

Pre-market Notification Details

DeNovo IDDEN140010
Device Name:PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM
ClassificationSevere Combined Immunodeficiency Disorder (scid) Newborn Screening Test System
Applicant WALLAC OY 940 Winter Street Waltham,  MA  02451
ContactKay A Taylor
Product CodePJI  
CFR Regulation Number866.5930 [🔎]
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 BoardPathology
Classification AdvisoryImmunology
TypeDirect
Date Received2014-02-19
Decision Date2014-12-15
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06438147331826 DEN140010 000
06438147331819 DEN140010 000
06438147331802 DEN140010 000

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