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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apolipoproteins
510(k) Number K072977
Device Name DIAZYME APOLIPOPROTEIN A-1 ASSAY
Applicant
GENERAL ATOMICS
12889 GREGG COURT
POWAY,  CA  92064
Applicant Contact Abhijit Datta
Correspondent
GENERAL ATOMICS
12889 GREGG COURT
POWAY,  CA  92064
Correspondent Contact Abhijit Datta
Regulation Number862.1475
Classification Product Code
MSJ  
Subsequent Product Codes
JIT   JJX  
Date Received10/22/2007
Decision Date 07/16/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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