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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urease And Glutamic Dehydrogenase, Urea Nitrogen
510(k) Number K070146
Device Name ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP
Applicant
Horiba Abx
Parc Euromedecine
Rue Du Caducee Bp7290
Montpellier Cedex 4,  FR 34184
Applicant Contact PASCAL MACZIOLA
Correspondent
Horiba Abx
Parc Euromedecine
Rue Du Caducee Bp7290
Montpellier Cedex 4,  FR 34184
Correspondent Contact PASCAL MACZIOLA
Regulation Number862.1770
Classification Product Code
CDQ  
Subsequent Product Code
JJY  
Date Received01/16/2007
Decision Date 10/12/2007
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
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