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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, Cholesterol Via Esterase-Oxidase, Hdl
510(k) Number K111516
FOIA Releasable 510(k) K111516
Device Name NMR LIPOPROFILE (R) TEST AND NMR PROFILER
Applicant
Liposcience, Inc.
2500 Sumner Blvd.
Raleigh,  NC  27616
Applicant Contact SUZETTE M WARNER
Correspondent
Liposcience, Inc.
2500 Sumner Blvd.
Raleigh,  NC  27616
Correspondent Contact SUZETTE M WARNER
Regulation Number862.1475
Classification Product Code
LBS  
Subsequent Product Codes
CDT   MRR  
Date Received06/01/2011
Decision Date 09/27/2011
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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