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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nadh Oxidation/Nad Reduction, Alt/Sgpt
510(k) Number K974003
Device Name ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30
Applicant
Diagnostic Chemicals , Ltd.
West Royalty Industrial Park,
Charlottetown, P.E.I.,  CA C1E 2A6
Applicant Contact KAREN CALLBECK
Correspondent
Diagnostic Chemicals , Ltd.
West Royalty Industrial Park,
Charlottetown, P.E.I.,  CA C1E 2A6
Correspondent Contact KAREN CALLBECK
Regulation Number862.1030
Classification Product Code
CKA  
Date Received10/21/1997
Decision Date 12/05/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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