FDA.reportPublic FDA data

De Novo DEN040002

Device
NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970
Contact
cindy lloyd
De Novo number
DEN040002
Product code
NQL
Regulation
862.1055
Classification name
system, test, amino acids, free carnitines and acylcarnitines tandem mass spectrometry
Decision
granted (DENG)
Decision date
2004-08-24
Date received
2004-07-02
Classification advisory
Clinical Chemistry
Review advisory
Clinical Chemistry
Type
Post-NSE

Current FDA Classification#

Product code
NQL
Device name
System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
Medical specialty
Clinical Chemistry
Device class
2
Regulation
862.1055
Implant
N
Life sustain/support
N