ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT

Azo Dye, Calcium

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 Calcium As Cp, Abx Pentra Urine Control L/h, Abx Pentra Multical, Abx Pentra N Control, And Abx Pentra P Cont.

Pre-market Notification Details

Device IDK123171
510k NumberK123171
Device Name:ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT
ClassificationAzo Dye, Calcium
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 CodeCJY  
Subsequent Product CodeJIX
Subsequent Product CodeJJY
CFR Regulation Number862.1145 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-09
Decision Date2013-07-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03610230005750 K123171 000

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