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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Esterase--Oxidase, Cholesterol
510(k) Number K946063
Device Name TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL
Applicant
Cholestech Corp.
3347 Investment Blvd.
Hayward,  CA  94545
Applicant Contact GARY HEWETT
Correspondent
Cholestech Corp.
3347 Investment Blvd.
Hayward,  CA  94545
Correspondent Contact GARY HEWETT
Regulation Number862.1175
Classification Product Code
CHH  
Date Received11/15/1994
Decision Date 02/22/1995
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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