Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact