Extended Lipid Panel Assay
K-Number: K181373 · 2018-10-18
Decision Date2018-10-18
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Extended Lipid Panel Assay is a medical device manufactured by Laboratory Corporation of America Holdings. It received FDA 510(k) clearance on 2018-10-18 under approval number K181373. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Extended Lipid Panel Assay?
Extended Lipid Panel Assay is a medical device that received FDA 510(k) clearance on 2018-10-18. It is manufactured by Laboratory Corporation of America Holdings. The 510(k) number is K181373.
When was Extended Lipid Panel Assay approved by the FDA?
Extended Lipid Panel Assay received FDA 510(k) clearance on 2018-10-18, under approval number K181373.
What company makes Extended Lipid Panel Assay?
Extended Lipid Panel Assay is manufactured by Laboratory Corporation of America Holdings.
What is the FDA product code for Extended Lipid Panel Assay?
The FDA product code for Extended Lipid Panel Assay is CHH.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.