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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 K943599
Device Name CHEM TRAK ACCUMETER
Applicant
Chemtrak, Inc.
929 E. Arques Ave.
Sunnyvale,  CA  94086
Correspondent
Chemtrak, Inc.
929 E. Arques Ave.
Sunnyvale,  CA  94086
Regulation Number862.1175
Classification Product Code
CHH  
Date Received07/06/1994
Decision Date 03/21/1995
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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