Extended Lipid Panel Assay— 510(k) K181373

Substantially Equivalent

Laboratory Corporation of America Holdings

FDA 510(k) clearance K181373 for Extended Lipid Panel Assay, Substantially Equivalent on 2018-10-18. Applicant: Laboratory Corporation of America Holdings. Device class: 1.

Clearance details

Applicant
Laboratory Corporation of America Holdings
Product code
Code CHH
Device class
Class 1
Regulation
21 CFR 862.1175
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Morrisville, NC, US
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