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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 K905405
Device Name CHEMTRAK ACCUMETER CHOLESTEROL TEST
Applicant
Chemtrak, Inc.
929 E. Arques Ave.
Sunnyvale,  CA  94086
Applicant Contact JERRY GIN
Correspondent
Chemtrak, Inc.
929 E. Arques Ave.
Sunnyvale,  CA  94086
Correspondent Contact JERRY GIN
Regulation Number862.1175
Classification Product Code
CHH  
Date Received12/03/1990
Decision Date 03/19/1991
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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