NMR Profiler and NMR Lipoprofile Assay, Controls

FDA 510(k) K063841 · Liposcience

Substantially Equivalent

510(k) numberK063841

Submission

Device name
NMR Profiler and NMR Lipoprofile Assay, Controls
Applicant
Liposcience
Washington, DC, US
Received
December 26, 2006
Decision date
July 23, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MRR – System, Test, Low Density, Lipoprotein
Device class
Class I (low risk)
Regulation
21 CFR 862.1475
Specialty
Clinical Chemistry

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More from Polymer Technology Systems, Inc.

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Questions and answers

When was NMR Profiler and NMR Lipoprofile Assay, Controls cleared by the FDA?

NMR Profiler and NMR Lipoprofile Assay, Controls (K063841) received a 510(k) decision of Substantially Equivalent on July 23, 2008, 575 days after the submission was received.

What is the product code of K063841?

The FDA product code is MRR – System, Test, Low Density, Lipoprotein, a Class I (low risk) device regulated under 21 CFR 862.1475.