ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL

Bromcresol Green Dye-binding, Albumin

HORIBA ABX

The following data is part of a premarket notification filed by Horiba Abx with the FDA for Abx Pentra Albumin Cp, Abx Pentra Micro-albumin Cp, Abx Pentra Total Protein Cp, Abx Pentra Multical.

Pre-market Notification Details

Device IDK060434
510k NumberK060434
Device Name:ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL
ClassificationBromcresol Green Dye-binding, Albumin
Applicant HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE Montpellier, Herault,  FR 34184
ContactTim Lawton
CorrespondentTim Lawton
HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE Montpellier, Herault,  FR 34184
Product CodeCIX  
Subsequent Product CodeCEK
Subsequent Product CodeDCF
Subsequent Product CodeJIT
Subsequent Product CodeJIX
Subsequent Product CodeJJY
CFR Regulation Number862.1035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-02-21
Decision Date2007-06-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03610230005187 K060434 000
03610230005224 K060434 000

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