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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K904082
Device Name CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE 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 Number862.1345
Classification Product Code
CGA  
Date Received09/05/1990
Decision Date 12/26/1990
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
Recalls CDRH Recalls
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