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510(k) Data Aggregation
K Number
K173568Device Name
NeoBase 2 Non-derivatized MSMS Kit
Manufacturer
Wallac Oy, Subsidiary of PerkinElmer, Inc.
Date Cleared
2018-09-04
(288 days)
Product Code
NQL
Regulation Number
862.1055Why did this record match?
Applicant Name (Manufacturer) :
Wallac Oy, Subsidiary of PerkinElmer, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeoBase™ 2 Non-derivatized MSMS kit is intended for the measurement and evaluation of amino acid, succinylacetone, free carnitine, acylcarnitine, nucleoside and lysophospholipid concentrations (Table 1) with a tandem mass spectrometer from newborn heel prick blood specimens dried on filter paper. Quantitative analytis of these analytes and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.
Device Description
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