FDA 510(k) Application Details - DEN040002

Device Classification Name	System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry   More FDA Info for this Device
510(K) Number	DEN040002
Device Name	System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
Applicant	PERKINELMER LIFE SCIENCES, INC. 3985 EASTERN ROAD NORTON, OH 44203 US Other 510(k) Applications for this Company
Contact	CINDY LLOYD Other 510(k) Applications for this Contact
Regulation Number	862.1055   More FDA Info for this Regulation Number
Classification Product Code	NQL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2004
Decision Date	08/24/2004
Decision	DENG -
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review