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 ID: DEN200044
• Device Name: Eonis SCID-SMA Kit
• Classification: Spinal Muscular Atrophy Newborn Screening Test System
• Applicant: PerkinElmer Inc. 940 Winter Street Waltham, MA 02451
• Contact: Casey Fox
• Product Code: QUE
• CFR Regulation Number: 866.5980 [🔎]
• Decision: Granted (DENG)
• 510(k) Premarket Notification: Device 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 Board: Molecular Genetics
• Classification Advisory: Immunology
• Type: Direct
• Date Received: 2020-07-08
• Decision Date: 2022-11-09
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06438147377756	DEN200044	000
06438147377732	DEN200044	000