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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo Colorimetry, Bilirubin
510(k) Number K060325
Device Name ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P
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 Number862.1110
Classification Product Code
CIG  
Subsequent Product Codes
JIX   JJY  
Date Received02/09/2006
Decision Date 08/16/2006
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
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