ABX PENTRA 400 : CRP

C-reactive Protein, Antigen, Antiserum, And Control

HORIBA ABX

The following data is part of a premarket notification filed by Horiba Abx with the FDA for Abx Pentra 400 : Crp.

Pre-market Notification Details

Device IDK061138
510k NumberK061138
Device Name:ABX PENTRA 400 : CRP
ClassificationC-reactive Protein, Antigen, Antiserum, And Control
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 CodeDCK  
CFR Regulation Number866.5270 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-24
Decision Date2006-09-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03610230005477 K061138 000
03610230004821 K061138 000
03610230004791 K061138 000

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