Device Classification Name |
system, test, amino acids, free carnitines and acylcarnitines tandem mass spectrometry
|
De Novo Number |
DEN040002 |
510(K) Number |
K031878
|
Device Name |
NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970 |
Requester |
perkinelmer life sciences, inc. |
3985 eastern road |
norton,
OH
44203
|
|
Contact |
cindy lloyd |
|
Regulation Number | 862.1055
|
Classification Product Code |
|
Date Received | 07/02/2004 |
Decision Date | 08/24/2004 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Clinical Chemistry
|
Review Advisory Committee |
Clinical Chemistry
|
Classification Order |
Classification Order
|
Type |
Post-NSE
|
|
|