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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 K890334
Device Name TOTAL CHOLESTEROL REAGENT
Applicant
Alpkem Corp.
Box 1260
Clackamas,  OR  97015
Applicant Contact RAYMOND L PAVITT
Correspondent
Alpkem Corp.
Box 1260
Clackamas,  OR  97015
Correspondent Contact RAYMOND L PAVITT
Regulation Number862.1175
Classification Product Code
CHH  
Date Received01/23/1989
Decision Date 05/03/1989
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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