HORIBA ABX SAS - FDA 510(k) Cleared Devices
17
Total
17
Cleared
0
Denied
HORIBA ABX SAS has 17 FDA 510(k) cleared medical devices. Based in Montpellier Cedex 4, FR.
Latest FDA clearance: May 2024. 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.
17 devices
Cleared
May 21, 2024
Yumizen H2500
Hematology
244d
Cleared
May 10, 2021
Yumizen C1200 Creatinine PAP
Chemistry
497d
Cleared
Jun 26, 2020
Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200...
Immunology
190d
Cleared
Jun 25, 2020
Yumizen C1200 CRP
Immunology
335d
Cleared
Mar 06, 2020
Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid...
Immunology
267d
Cleared
Oct 03, 2019
Yumizen C1200 CRP
Chemistry
70d
Cleared
Aug 30, 2019
Yumizen C1200 ALP, Yumizen C1200 Albumin
Chemistry
113d
Cleared
Jul 26, 2019
Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
Chemistry
63d
Cleared
Nov 01, 2017
ABX MICROS ES 60 OT and ABX MICROS ES 60 CT
Hematology
271d
Cleared
Dec 09, 2015
PENTRA XLR
Hematology
225d
Cleared
Dec 20, 2014
ABX MICROS ES 60 CT
Hematology
229d
Cleared
Jul 11, 2014
ABX PENTRA MICRO ALB CONTROL L/H
Chemistry
224d
Cleared
Jul 03, 2013
ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL,...
Chemistry
267d
Cleared
Apr 30, 2012
ABX PENTRA CREATININE 120 CP
Chemistry
431d
Cleared
Nov 08, 2011
PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT
Chemistry
316d
Cleared
Aug 10, 2011
ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N...
Chemistry
204d
Cleared
Oct 16, 2009
ABX PENTRA TPU CAL, MODEL A11A01898
Chemistry
56d