ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL

Alkaline Picrate, Colorimetry, Creatinine

HORIBA ABX S.A.S.

The following data is part of a premarket notification filed by Horiba Abx S.a.s. with the FDA for Abx Pentra Creatinine 120 Cp; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P Control; Abx Pentra Urine Control.

Pre-market Notification Details

Device IDK110530
510k NumberK110530
Device Name:ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL
ClassificationAlkaline Picrate, Colorimetry, Creatinine
Applicant HORIBA ABX S.A.S. PARC EUROMEDECINE RUE DU CADUCEE-BP 7290 Montpellier Cedex 4, Herault,  FR 34184
ContactCaroline Ferrer
CorrespondentCaroline Ferrer
HORIBA ABX S.A.S. PARC EUROMEDECINE RUE DU CADUCEE-BP 7290 Montpellier Cedex 4, Herault,  FR 34184
Product CodeCGX  
Subsequent Product CodeJIX
Subsequent Product CodeJJY
CFR Regulation Number862.1225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-02-24
Decision Date2012-04-30
Summary:summary

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