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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 K073488
Device Name DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX
Applicant
Diazyme Laboratories
12889 Gregg Ct.
Poway,  CA  92064
Applicant Contact CHARLES YU
Correspondent
Diazyme Laboratories
12889 Gregg Ct.
Poway,  CA  92064
Correspondent Contact CHARLES YU
Regulation Number862.1475
Classification Product Code
MSJ  
Subsequent Product Codes
JIT   JJX  
Date Received10/22/2007
Decision Date 03/07/2008
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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