ABX PENTRA TPU CAL, MODEL A11A01898

Calibrator, Secondary

HORIBA ABX SAS

The following data is part of a premarket notification filed by Horiba Abx Sas with the FDA for Abx Pentra Tpu Cal, Model A11a01898.

Pre-market Notification Details

Device IDK092570
510k NumberK092570
Device Name:ABX PENTRA TPU CAL, MODEL A11A01898
ClassificationCalibrator, Secondary
Applicant HORIBA ABX SAS PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 Montpellier,  FR 34184
ContactCaroline Ferrer
CorrespondentCaroline Ferrer
HORIBA ABX SAS PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 Montpellier,  FR 34184
Product CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-08-21
Decision Date2009-10-16
Summary:summary

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