FDA 510(k), K063841, NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS
FDA 510(k), K063841, NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS
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510(K) Number: K063841
Device Name: NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS
Manufacturer:
Device Classification Name: System, Test, Low Density, Lipoprotein
Regulation Number: 862.1475
Classification Product Code: MRR
Date Received: 12/26/2006
Decision Date: 07/23/2008
Regulation Medical Specialty: Clinical Chemistry
Device Name: NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS
Manufacturer:
Device Classification Name: System, Test, Low Density, Lipoprotein
Regulation Number: 862.1475
Classification Product Code: MRR
Date Received: 12/26/2006
Decision Date: 07/23/2008
Regulation Medical Specialty: Clinical Chemistry