NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U

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 Non-derivatized Msms Kit Model 3040-001u.

Pre-market Notification Details

Device IDK093916
510k NumberK093916
Device Name:NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U
ClassificationSystem, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
Applicant PERKINELMER, INC. 8275 CARLOWAY ROAD Indianapolis,  IN  46236
ContactKay Taylor
CorrespondentKay Taylor
PERKINELMER, INC. 8275 CARLOWAY ROAD Indianapolis,  IN  46236
Product CodeNQL  
CFR Regulation Number862.1055 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-22
Decision Date2010-08-23
Summary:summary

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