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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 K943279
Device Name ACCUMETER HDL CHOLESTEROL TEST
Applicant
Chemtrak, Inc.
929 E. Arques Ave.
Sunnyvale,  CA  94086
Applicant Contact JILL FINDLAY
Correspondent
Chemtrak, Inc.
929 E. Arques Ave.
Sunnyvale,  CA  94086
Correspondent Contact JILL FINDLAY
Regulation Number862.1475
Classification Product Code
LBS  
Subsequent Product Code
JJX  
Date Received07/07/1994
Decision Date 05/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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