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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name alkaline picrate, colorimetry, creatinine
510(k) Number K110530
Device Name ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL
Applicant
HORIBA ABX S.A.S.
PARC EUROMEDECINE
RUE DU CADUCEE-BP 7290
MONTPELLIER CEDEX 4, HERAULT,  FR 34184
Applicant Contact CAROLINE FERRER
Correspondent
HORIBA ABX S.A.S.
PARC EUROMEDECINE
RUE DU CADUCEE-BP 7290
MONTPELLIER CEDEX 4, HERAULT,  FR 34184
Correspondent Contact CAROLINE FERRER
Regulation Number862.1225
Classification Product Code
CGX  
Subsequent Product Codes
JIX   JJY  
Date Received02/24/2011
Decision Date 04/30/2012
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
Recalls CDRH Recalls
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