# DEN040002: Neogram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, Model MS-8970

- Pathway: De Novo (Post-NSE)
- Applicant: Perkinelmer Life Sciences, Inc.
- Decided: Aug 24, 2004 after 53 days
- Product code: NQL (System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry)
- Device class: 2
- Regulation: 21 CFR 862.1055
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K083130: Neobase Non-Derivatized MSMS Kit, Model 3040 (2009), 3 descendants of its own
- K093916: Neobase Non-Derivatized MSMS Kit Model 3040-001U (2010), 2 descendants of its own
- K173568: NeoBase 2 Non-derivatized MSMS Kit (2018), 1 descendant of its own
- K193103: NeoBase 2 Non-derivatized MSMS Kit (2020), 0 descendants of its own

Source page: https://510kreport.com/device/DEN040002
Methodology: https://510kreport.com/methodology