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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 K063841
FOIA Releasable 510(k) K063841
Device Name NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS
Applicant
Liposcience
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact MARK A DEL VECCHIO
Correspondent
Liposcience
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact MARK A DEL VECCHIO
Regulation Number862.1475
Classification Product Code
MRR  
Subsequent Product Codes
CDT   JIT   JJY   LBS  
Date Received12/26/2006
Decision Date 07/23/2008
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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