NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970

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

PERKINELMER LIFE SCIENCES, INC.

The following data is part of a De Novo classification by Perkinelmer Life Sciences, Inc. with the FDA for Neogram Amino Acids And Acylcarnitines Tandem Mass Spectrometry Kit, Model Ms-8970.

Pre-market Notification Details

DeNovo IDDEN040002
Device Name:NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970
ClassificationSystem, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
Applicant PERKINELMER LIFE SCIENCES, INC. 3985 Eastern Road Norton,  OH  44203
ContactCindy Lloyd
Product CodeNQL  
CFR Regulation Number862.1055 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationK031878
Review Advisory BoardClinical Chemistry
Classification AdvisoryClinical Chemistry
TypePost-NSE
Date Received2004-07-02
Decision Date2004-08-24
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06438147283842 DEN040002 000
06438147283835 DEN040002 000

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