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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 K071706
Device Name ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)
Applicant
Clinical Data, Inc.
1075 W. Lambert Rd.
Brea,  CA  92821 -2944
Applicant Contact WYNN STOCKING
Correspondent
Clinical Data, Inc.
1075 W. Lambert Rd.
Brea,  CA  92821 -2944
Correspondent Contact WYNN STOCKING
Regulation Number862.1475
Classification Product Code
LBS  
Subsequent Product Code
JIT  
Date Received06/21/2007
Decision Date 12/20/2007
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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