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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Low Density, Lipoprotein
510(k) Number K020575
Device Name ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS
Applicant
ELAN DIAGNOSTICS
1075 W. LAMBERT RD., SUITE D
BREA,  CA  92821
Applicant Contact WYNN STOCKING
Correspondent
ELAN DIAGNOSTICS
1075 W. LAMBERT RD., SUITE D
BREA,  CA  92821
Correspondent Contact WYNN STOCKING
Regulation Number862.1475
Classification Product Code
MRR  
Subsequent Product Code
JIT  
Date Received02/21/2002
Decision Date 04/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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