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FDA 510(k)

NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS

K-Number: K063841 · 2008-07-23

ApplicantLiposcience
Decision Date2008-07-23
Product CodeMRR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Liposcience. It received FDA 510(k) clearance on 2008-07-23 under 510(k) number K063841. The device is classified under product code MRR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS?

NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS is a medical device that received FDA 510(k) clearance on 2008-07-23. The listed applicant is Liposcience. The 510(k) number is K063841.

When did NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS receive FDA 510(k) clearance?

NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS received FDA 510(k) clearance on 2008-07-23, under 510(k) number K063841.

Who is the listed applicant for NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS?

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

What is the FDA product code for NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS?

The FDA product code for NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS is MRR.

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Other records listing Liposcience as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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