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FDA 510(k)

NMR LIPOPROFILE (R) TEST AND NMR PROFILER

K-Number: K111516 · 2011-09-27

ApplicantLiposcience, Inc.
Decision Date2011-09-27
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NMR LIPOPROFILE (R) TEST AND NMR PROFILER is the device name listed in this FDA 510(k) record. The listed applicant is Liposcience, Inc.. It received FDA 510(k) clearance on 2011-09-27 under 510(k) number K111516. The device is classified under product code LBS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NMR LIPOPROFILE (R) TEST AND NMR PROFILER?

NMR LIPOPROFILE (R) TEST AND NMR PROFILER is a medical device that received FDA 510(k) clearance on 2011-09-27. The listed applicant is Liposcience, Inc.. The 510(k) number is K111516.

When did NMR LIPOPROFILE (R) TEST AND NMR PROFILER receive FDA 510(k) clearance?

NMR LIPOPROFILE (R) TEST AND NMR PROFILER received FDA 510(k) clearance on 2011-09-27, under 510(k) number K111516.

Who is the listed applicant for NMR LIPOPROFILE (R) TEST AND NMR PROFILER?

The FDA 510(k) record lists Liposcience, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NMR LIPOPROFILE (R) TEST AND NMR PROFILER?

The FDA product code for NMR LIPOPROFILE (R) TEST AND NMR PROFILER is LBS.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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