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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 K860713
Device Name LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM.
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 Number862.1440
Classification Product Code
CFJ  
Date Received02/26/1986
Decision Date 04/24/1986
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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