FDA 510(k) Applications for Medical Device Product Code "NQL"
(System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry)

FDA 510(k) Number Applicant Device Name Decision Date
K193103 PerkinElmer Inc. NeoBase 2 Non-derivatized MSMS Kit 02/07/2020
DEN040002 PERKINELMER LIFE SCIENCES, INC. NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970 08/24/2004
K093916 PERKINELMER, INC. NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U 08/23/2010
K083130 PERKINELMER, INC. NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 07/09/2009
K173568 Wallac Oy, Subsidiary of PerkinElmer, Inc. NeoBase 2 Non-derivatized MSMS Kit 09/04/2018


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