ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL)

Counter, Differential Cell

HORIBA ABX SAS

The following data is part of a premarket notification filed by Horiba Abx Sas with the FDA for Abx Micros Es 60 Ct; (open Tube Model), (close Tube Model).

Pre-market Notification Details

Device IDK141161
510k NumberK141161
Device Name:ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL)
ClassificationCounter, Differential Cell
Applicant HORIBA ABX SAS PARC EUROMEDECINE RUE DU CADUCEE - BP7290 Montpellier,  FR 34184
ContactFerrer Caroline
CorrespondentFerrer Caroline
HORIBA ABX SAS PARC EUROMEDECINE RUE DU CADUCEE - BP7290 Montpellier,  FR 34184
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-05
Decision Date2014-12-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03610230006115 K141161 000
03610230006108 K141161 000
03610230006061 K141161 000
03610230006047 K141161 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.