Cleared Traditional

NMR LIPOPROFILE (R) TEST AND NMR PROFILER

K111516 · Liposcience, Inc. · Chemistry

Sep 2011

Decision

118d

Days

Class 1

Risk

About This 510(k) Submission

K111516 is an FDA 510(k) clearance for the NMR LIPOPROFILE (R) TEST AND NMR PROFILER, a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBS), submitted by Liposcience, Inc. (Raleigh, US). The FDA issued a Cleared decision on September 27, 2011, 118 days after receiving the submission on June 1, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number	K111516 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 01, 2011
Decision Date	September 27, 2011
Days to Decision	118 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	LBS — Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.1475