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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, Ast/Sgot
510(k) Number K060318
Device Name HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
Applicant
Horiba Abx
Parc Euromedecine
Rue Du Caducee
Montpellier,  FR 34184
Applicant Contact TIM LAWTON
Correspondent
Horiba Abx
Parc Euromedecine
Rue Du Caducee
Montpellier,  FR 34184
Correspondent Contact TIM LAWTON
Regulation Number862.1100
Classification Product Code
CIT  
Subsequent Product Codes
JIX   JJY  
Date Received02/08/2006
Decision Date 08/08/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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