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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 K982341
Device Name DIRECT HDL-CHOLESTROL LIQUID
Applicant
Randox Laboratories, Ltd.
Ardmore, Diamond Rd.
Crumlin, Co. Antrim,  GB BT29 4QY
Applicant Contact P ARMSTRONG
Correspondent
Randox Laboratories, Ltd.
Ardmore, Diamond Rd.
Crumlin, Co. Antrim,  GB BT29 4QY
Correspondent Contact P ARMSTRONG
Regulation Number862.1475
Classification Product Code
LBS  
Date Received06/22/1998
Decision Date 07/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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