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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ldl & Vldl Precipitation, Hdl
510(k) Number K072523
Device Name DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS
Applicant
General Atomics
12889 Gregg Ct.
Poway,  CA  92064
Applicant Contact CHARLES YU
Correspondent
General Atomics
12889 Gregg Ct.
Poway,  CA  92064
Correspondent Contact CHARLES YU
Regulation Number862.1475
Classification Product Code
LBR  
Subsequent Product Code
JJX  
Date Received09/07/2007
Decision Date 01/22/2008
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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