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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name multi-analyte controls, all kinds (assayed)
510(k) Number K133676
Device Name ABX PENTRA MICRO ALB CONTROL L/H
Applicant
HORIBA ABX SAS
PARC EUROMEDECINE
RUE DU CADUCEE
MONTPELLIER,  FR 34184
Applicant Contact CAROLINE FERRER
Correspondent
HORIBA ABX SAS
PARC EUROMEDECINE
RUE DU CADUCEE
MONTPELLIER,  FR 34184
Correspondent Contact CAROLINE FERRER
Regulation Number862.1660
Classification Product Code
JJY  
Date Received11/29/2013
Decision Date 07/11/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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