Eonis SCID-SMA Kit

Severe Combined Immunodeficiency Disorder (scid) Newborn Screening Test System

PerkinElmer Inc

The following data is part of a premarket notification filed by Perkinelmer Inc with the FDA for Eonis Scid-sma Kit.

Pre-market Notification Details

Device IDK203035
510k NumberK203035
Device Name:Eonis SCID-SMA Kit
ClassificationSevere Combined Immunodeficiency Disorder (scid) Newborn Screening Test System
Applicant PerkinElmer Inc 940 Winter St Waltham,  MA  02451
ContactEva Nalian
CorrespondentCasey Fox
PerkinElmer Inc 940 Winter St Waltham,  MA  02451
Product CodePJI  
CFR Regulation Number866.5930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-05
Decision Date2022-11-09

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