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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 K072115
Device Name ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H
Applicant
HORIBA ABX
PARC EUROMEDECINE
RUE DU CADUCEE
MONTPELLIER, HERAULT,  FR 34184
Applicant Contact OLIVIER DUCAMP
Correspondent
HORIBA ABX
PARC EUROMEDECINE
RUE DU CADUCEE
MONTPELLIER, HERAULT,  FR 34184
Correspondent Contact OLIVIER DUCAMP
Regulation Number862.1225
Classification Product Code
CGX  
Subsequent Product Codes
CEK   JIX   JJY  
Date Received08/01/2007
Decision Date 11/30/2007
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
Recalls CDRH Recalls
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