Medical Device Manufacturer · FR , Montpellier Cedex 4

HORIBA ABX SAS - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 2009
17
Total
17
Cleared
0
Denied
FDA 510(k) Regulatory Record - HORIBA ABX SAS Hematology ✕
4 devices
1-4 of 4
Cleared May 21, 2024
Yumizen H2500
K232946 · GKZ
Hematology · 244d
Cleared Nov 01, 2017
ABX MICROS ES 60 OT and ABX MICROS ES 60 CT
K170353 · GKZ
Hematology · 271d
Cleared Dec 09, 2015
PENTRA XLR
K151133 · GKZ
Hematology · 225d
Cleared Dec 20, 2014
ABX MICROS ES 60 CT
K141161 · GKZ
Hematology · 229d
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