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 IDDEN180056
Device Name:GSP Neonatal Creatine Kinase - MM Kit
ClassificationMuscular Dystrophy Newborn Screening Test
Applicant PerkinElmer Inc. 940 Winter Street Waltham,  MA  02451
ContactBrian Ciccariello
Product CodeQJE  
CFR Regulation Number862.1506 [🔎]
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 BoardClinical Chemistry
Classification AdvisoryClinical Chemistry
Date Received2018-10-11
Decision Date2019-12-12
Reclassification Order:Reclassification Order

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