Cleared Traditional

NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS

K063841 · Liposcience · Chemistry

Jul 2008

Decision

575d

Days

Class 1

Risk

About This 510(k) Submission

K063841 is an FDA 510(k) clearance for the NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS, a System, Test, Low Density, Lipoprotein (Class I — General Controls, product code MRR), submitted by Liposcience (Washington, Dc, US). The FDA issued a Cleared decision on July 23, 2008, 575 days after receiving the submission on December 26, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number	K063841 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 26, 2006
Decision Date	July 23, 2008
Days to Decision	575 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF