NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS— 510(k) K063841

Name: FDA 510(k) clearance K063841
Creator: U.S. Food and Drug Administration
Published: 2008-07-23

Substantially Equivalent

Liposcience

FDA 510(k) clearance K063841 for NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS, Substantially Equivalent on 2008-07-23. Applicant: Liposcience. Device class: 1.

Clearance details

Applicant: Liposcience
Product code: Code MRR
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 2006-12-26
Decision date: 2008-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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