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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Low Density, Lipoprotein
510(k) Number K161691
Device Name Direct LDL Cholesterol (LDL)
Applicant
Randox Laboratories Limited
55 Diamond Rd.
Crumlin
Crumlin,  GB BT29 4QY
Applicant Contact PAULINE ARMSTRONG
Correspondent
Randox Laboratories Limited
55 Diamond Rd.
Crumlin
Crumlin,  GB BT29 4QY
Correspondent Contact Pauline Armstong
Regulation Number862.1475
Classification Product Code
MRR  
Date Received06/20/2016
Decision Date 03/20/2017
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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