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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name C-Reactive Protein, Antigen, Antiserum, And Control
510(k) Number K061138
Device Name ABX PENTRA 400 : CRP
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 Number866.5270
Classification Product Code
DCK  
Subsequent Product Code
JIS  
Date Received04/24/2006
Decision Date 09/29/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
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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