GSP Neonatal Creatine Kinase - MM Kit

Muscular Dystrophy Newborn Screening Test

PerkinElmer Inc.

The following data is part of a De Novo classification by Perkinelmer Inc. with the FDA for Gsp Neonatal Creatine Kinase - Mm Kit.

Pre-market Notification Details

• DeNovo ID: DEN180056
• Device Name: GSP Neonatal Creatine Kinase - MM Kit
• Classification: Muscular Dystrophy Newborn Screening Test
• Applicant: PerkinElmer Inc. 940 Winter Street Waltham, MA 02451
• Contact: Brian Ciccariello
• Product Code: QJE
• CFR Regulation Number: 862.1506 [🔎]
• 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: Clinical Chemistry
• Classification Advisory: Clinical Chemistry
• Type: Direct
• Date Received: 2018-10-11
• Decision Date: 2019-12-12
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06438147362615	DEN180056	000