FDA 510(k) Application Details - K072977

Device Classification Name	Apolipoproteins   More FDA Info for this Device
510(K) Number	K072977
Device Name	Apolipoproteins
Applicant	GENERAL ATOMICS 12889 GREGG COURT POWAY, CA 92064 US Other 510(k) Applications for this Company
Contact	Abhijit Datta Other 510(k) Applications for this Contact
Regulation Number	862.1475   More FDA Info for this Regulation Number
Classification Product Code	MSJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/22/2007
Decision Date	07/16/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review