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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 K852863
Device Name CHOLESTEROL METHOD
Applicant
Catachem, Inc.
6 N. Pearl St.
Port Chester,  NY  10573
Applicant Contact LUIS LEON
Correspondent
Catachem, Inc.
6 N. Pearl St.
Port Chester,  NY  10573
Correspondent Contact LUIS LEON
Regulation Number862.1175
Classification Product Code
CHH  
Date Received07/08/1985
Decision Date 07/23/1985
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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