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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
510(k) Number K162593
Device Name HDL-Cholesterol Gen.4
Applicant
Roche Diagnostics Operations (Rdo)
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact Barbara McWhorter
Correspondent
Roche Diagnostics Operations (Rdo)
9115 Hague Rd.
Suite 114
Indianapolis,  IN  46250
Correspondent Contact Barbara McWhorter
Regulation Number862.1475
Classification Product Code
LBS  
Date Received09/16/2016
Decision Date 10/19/2016
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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