GSP Neonatal Total Galactose Kit

Enzymatic Methods, Galactose

PerkinElmer Inc.

The following data is part of a premarket notification filed by Perkinelmer Inc. with the FDA for Gsp Neonatal Total Galactose Kit.

Pre-market Notification Details

Device IDK190335
501k NumberK190335
Device Name:GSP Neonatal Total Galactose Kit
ClassificationEnzymatic Methods, Galactose
Applicant PerkinElmer Inc. 940 Winter Street Waltham,  MA  02451
ContactBrian Ciccariello
CorrespondentBrian Ciccariello
PerkinElmer Inc. 940 Winter Street Waltham,  MA  02451
Product CodeJIA  
CFR Regulation Number862.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyClinical Chemistry
501k Review PanelClinical Chemistry
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-14
Decision Date2019-11-06

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