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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 K911578
Device Name CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION
Applicant
Cholestech Corp.
3347 Investment Blvd.
Hayward,  CA  94545
Applicant Contact LYNN BANFIELD
Correspondent
Cholestech Corp.
3347 Investment Blvd.
Hayward,  CA  94545
Correspondent Contact LYNN BANFIELD
Regulation Number862.1175
Classification Product Code
CHH  
Date Received03/27/1991
Decision Date 05/15/1991
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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