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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 K823500
Device Name CHOLESTEROL REAGENT
Applicant
Ac Biochemical Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Ac Biochemical Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1175
Classification Product Code
CHH  
Date Received11/24/1982
Decision Date 12/30/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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