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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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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 Number862.1055
Classification Product Code
NQL  
Date Received07/02/2004
Decision Date 08/24/2004
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Reclassification Order Reclassification Order
Type Post-NSE
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