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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
510(k) Number K852948
Device Name AMRESCO SUBST CONCEN, PRO #2432,BUF,NAD,2455,TRI
Applicant
Amresco, Inc.
P.O. Box 21009
South Euclid,  OH  44121
Applicant Contact TIMOTHY J BELCASTRO
Correspondent
Amresco, Inc.
P.O. Box 21009
South Euclid,  OH  44121
Correspondent Contact TIMOTHY J BELCASTRO
Regulation Number862.1440
Classification Product Code
CFJ  
Date Received07/11/1985
Decision Date 08/07/1985
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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