NeoBase 2 Non-derivatized MSMS Kit

System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry

PerkinElmer Inc.

The following data is part of a premarket notification filed by Perkinelmer Inc. with the FDA for Neobase 2 Non-derivatized Msms Kit.

Pre-market Notification Details

Device IDK193103
510k NumberK193103
Device Name:NeoBase 2 Non-derivatized MSMS Kit
ClassificationSystem, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
Applicant PerkinElmer Inc. 940 Winter Street Waltham,  MA  02451
ContactEva Nalian
CorrespondentEva Nalian
PerkinElmer Inc. 940 Winter Street Waltham,  MA  02451
Product CodeNQL  
CFR Regulation Number862.1055 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyClinical Chemistry
510k Review PanelClinical Chemistry
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-08
Decision Date2020-02-07

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