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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 K884936
Device Name ALANINE AMINOTRANSFERASE
Applicant
CATACHEM, INC.
6 NORTH PEARL ST.
PORT CHESTER,  NY  10573
Applicant Contact LUIS P LEON
Correspondent
CATACHEM, INC.
6 NORTH PEARL ST.
PORT CHESTER,  NY  10573
Correspondent Contact LUIS P LEON
Regulation Number862.1030
Classification Product Code
CKA  
Date Received11/25/1988
Decision Date 01/03/1989
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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