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510(k) DEN040002

NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970 by Perkinelmer Life Sciences, Inc. — Product Code NQL

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
August 24, 2004
Date Received
July 2, 2004
Clearance Type
Post-NSE
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
Device Class
Class II
Regulation Number
862.1055
Review Panel
CH
Submission Type

Amino acids, free carnitines and acylcarnitines test system is intended for the measurement and evaluation of amino acid, free carnitine and acylcarnitine concentrations from newborn whole blood filter paper samples. The quantitative analysis of the amino acids, free carnitines and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that should aid in identifying elevated levels of these metabolites for screening newborns for one or more of several metabolic disorders.

Other clearances by Perkinelmer Life Sciences, Inc.

  • K021541 — NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT (October 28, 2002)

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  • K093916 — NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U (August 23, 2010)
  • K083130 — NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 (July 9, 2009)