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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, Cpk Or Isoenzymes
510(k) Number K894715
Device Name CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS
Applicant
Catachem, Inc.
6 N. Pearl St.
Port Chester,  NY  10573
Applicant Contact LUIS P LEON
Correspondent
Catachem, Inc.
6 N. Pearl St.
Port Chester,  NY  10573
Correspondent Contact LUIS P LEON
Regulation Number862.1215
Classification Product Code
CGS  
Date Received07/25/1989
Decision Date 11/08/1989
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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