FDA 510(k), K111516, NMR LIPOPROFILE (R) TEST AND NMR PROFILER
FDA 510(k), K111516, NMR LIPOPROFILE (R) TEST AND NMR PROFILER
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510(K) Number: K111516
Device Name: NMR LIPOPROFILE (R) TEST AND NMR PROFILER
Manufacturer: LIPOSCIENCE, INC
Device Classification Name: ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl
Regulation Number: 862.1475
Classification Product Code: LBS
Date Received: 06/01/2011
Decision Date: 09/27/2011
Regulation Medical Specialty: Clinical Chemistry
Device Name: NMR LIPOPROFILE (R) TEST AND NMR PROFILER
Manufacturer: LIPOSCIENCE, INC
Device Classification Name: ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl
Regulation Number: 862.1475
Classification Product Code: LBS
Date Received: 06/01/2011
Decision Date: 09/27/2011
Regulation Medical Specialty: Clinical Chemistry