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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 K820950
Device Name TOTAL CHOLESTEROL REAGENT SET
Applicant
Sterling Biochemical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sterling Biochemical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1175
Classification Product Code
CHH  
Date Received04/06/1982
Decision Date 04/26/1982
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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