Medical Device Manufacturer · FR , Montpellier Cedex 4

HORIBA ABX SAS - FDA 510(k) Cleared Devices

18 submissions · 18 cleared · Since 2009

Recent clearances: Yumizen H550, Yumizen H2500, Yumizen C1200 Creatinine PAP

Total

Cleared

Denied

HORIBA ABX SAS has 18 FDA 510(k) cleared medical devices. Based in Montpellier Cedex 4, FR.

Latest FDA clearance: Sep 2026. Active since 2009. Primary specialty: Chemistry.

Browse the FDA 510(k) cleared devices submitted by HORIBA ABX SAS Filter by specialty or product code using the sidebar.

HORIBA ABX SAS is one of 270 FDA 510(k) medical device manufacturers from France in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - HORIBA ABX SAS

18 devices

1-12 of 18

Yumizen C1200 Creatinine PAP

K193649 · JFY

Chemistry · 497d

Cleared Jun 26, 2020

Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200...

Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid...

Yumizen C1200 ALP, Yumizen C1200 Albumin

K191245 · CJE

Chemistry · 113d

Cleared Jul 26, 2019

Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe

K191396 · CJY

Chemistry · 63d

Cleared Nov 01, 2017

ABX MICROS ES 60 OT and ABX MICROS ES 60 CT

HORIBA ABX SAS - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - HORIBA ABX SAS

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