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 Immunology ✕
3 devices
1-3 of 3
Cleared Jun 26, 2020
Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200...
K193525 · CZP
Immunology · 190d
Cleared Jun 25, 2020
Yumizen C1200 CRP
K192028 · DCK
Immunology · 335d
Cleared Mar 06, 2020
Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid...
K191562 · DBF
Immunology · 267d
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