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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 K803287
Device Name CHOLESTEROL REAGENT ENZYMATIC
Applicant
RAI, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
RAI, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1175
Classification Product Code
CHH  
Date Received12/30/1980
Decision Date 01/16/1981
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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