ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT

Assay, Glycosylated Hemoglobin

HORIBA ABX

The following data is part of a premarket notification filed by Horiba Abx with the FDA for Abx Pentra Hba1c Wb, Calibrator, Control And Hemolysis Reagent.

Pre-market Notification Details

Device IDK073309
510k NumberK073309
Device Name:ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT
ClassificationAssay, Glycosylated Hemoglobin
Applicant HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 Montpellier,  FR 34184
ContactOlivier Ducamp
CorrespondentOlivier Ducamp
HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 Montpellier,  FR 34184
Product CodeLCP  
Subsequent Product CodeJIX
Subsequent Product CodeJJY
CFR Regulation Number864.7470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-11-23
Decision Date2008-10-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03610230005415 K073309 000
03610230005408 K073309 000
03610230005392 K073309 000

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