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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Esterase--Oxidase, Cholesterol
510(k) Number K181373
Device Name Extended Lipid Panel Assay
Applicant
Laboratory Corporation of America Holdings
500 Perimeter Park Dr.
Morrisville,  NC  27560
Applicant Contact Suzette Warner
Correspondent
Laboratory Corporation of America Holdings
500 Perimeter Park Dr.
Morrisville,  NC  27560
Correspondent Contact Suzette Warner
Regulation Number862.1175
Classification Product Code
CHH  
Subsequent Product Codes
CDT   LBS   MSJ  
Date Received05/24/2018
Decision Date 10/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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