510(k) Report

FDA applicant

Liposcience

Raleigh, NC4 decisions2008–20140 recalls

FDA records 4 decisions for Liposcience (Raleigh, NC) from 2008 to 2014: 4 510(k) clearances. Most are in product codes NSU (Instrumentation For Clinical Multiplex Test…) and CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme…). Its devices cite 7 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Liposcience, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Liposcience’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2008: 12011: 12012: 12014: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Liposcience by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Liposcience’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NSUInstrumentation For Clinical Multiplex Test Systems1decision
  • CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides1decision
  • LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl1decision
  • MRRSystem, Test, Low Density, Lipoprotein1decision

Whose devices does it build on?

Its devices cite 7 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K063841NMR Profiler and NMR Lipoprofile Assay, ControlsLiposcience · 20082cite it
  • K113830Vantera Clinical AnalyzerLiposcience · 20121cites it
  • K111516NMR Lipoprofile (R) Test and NMR ProfilerLiposcience, Inc. · 20111cites it

What has FDA decided for it lately?

  • K133849Vantera Clinical AnalyzerLiposcience · 2014
  • K113830Vantera Clinical AnalyzerLiposcience · 2012
  • K111516NMR Lipoprofile (R) Test and NMR ProfilerLiposcience, Inc. · 2011
  • K063841NMR Profiler and NMR Lipoprofile Assay, ControlsLiposcience · 2008

All 3 as Liposcience →The one decision as Liposcience, Inc. →