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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetric Method, Triglycerides
510(k) Number K914033
Device Name CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST
Applicant
Cholestech Corp.
3347 Investment Blvd.
Hayward,  CA  94545
Applicant Contact SUSAN WILLSON
Correspondent
Cholestech Corp.
3347 Investment Blvd.
Hayward,  CA  94545
Correspondent Contact SUSAN WILLSON
Regulation Number862.1705
Classification Product Code
JGY  
Date Received09/10/1991
Decision Date 09/27/1991
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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