510(k) Report

Devices descending from DEN040002

4 later devices reach Neogram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083130Neobase Non-Derivatized MSMS Kit, Model 3040Perkinelmer, Inc.200932
+2K093916Neobase Non-Derivatized MSMS Kit Model 3040-001UPerkinelmer, Inc.20102—
+3K173568NeoBase 2 Non-derivatized MSMS KitWallac Oy, Subsidiary of Perkinelmer, Inc.20181—
+4K193103NeoBase 2 Non-derivatized MSMS KitPerkinelmer, Inc.20200—