Eonis SCID-SMA Kit

Spinal Muscular Atrophy Newborn Screening Test System

PerkinElmer Inc.

The following data is part of a De Novo classification by Perkinelmer Inc. with the FDA for Eonis Scid-sma Kit.

Pre-market Notification Details

DeNovo IDDEN200044
Device Name:Eonis SCID-SMA Kit
ClassificationSpinal Muscular Atrophy Newborn Screening Test System
Applicant PerkinElmer Inc. 940 Winter Street Waltham,  MA  02451
ContactCasey Fox
Product CodeQUE  
CFR Regulation Number866.5980 [🔎]
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 BoardMolecular Genetics
Classification AdvisoryImmunology
Date Received2020-07-08
Decision Date2022-11-09
Reclassification Order:Reclassification Order


Device IdentifiersubmissionNumberSupplement
06438147377756 DEN200044 000
06438147377732 DEN200044 000

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