Cleared Traditional

Extended Lipid Panel Assay

K181373 · Laboratory Corporation of America Holdings · Chemistry

Oct 2018

Decision

147d

Days

Class 1

Risk

About This 510(k) Submission

K181373 is an FDA 510(k) clearance for the Extended Lipid Panel Assay, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Laboratory Corporation of America Holdings (Morrisville, US). The FDA issued a Cleared decision on October 18, 2018, 147 days after receiving the submission on May 24, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number	K181373 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 24, 2018
Decision Date	October 18, 2018
Days to Decision	147 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF