Medical Device Manufacturer · FR , Montpellier Cedex 4

HORIBA ABX SAS

17 submissions · 17 cleared · Since 2009
17
Total
17
Cleared
0
Denied

HORIBA ABX SAS — FDA 510(k) Submissions

HORIBA ABX SAS has submitted 17 FDA 510(k) premarket notifications since 2009, of which 17 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Counter, Differential Cell, C-reactive Protein, Antigen, Antiserum, And Control, Enzymatic Method, Creatinine, Azo Dye, Calcium, Multi-analyte Controls, All Kinds (assayed) . Use the specialty filter in the sidebar to narrow results.

17 devices
1–17 of 17
Yumizen H2500
K232946 · GKZ Counter, Differential Cell · Hematology
May 2024 244d
Yumizen C1200 Creatinine PAP
K193649 · JFY Enzymatic Method, Creatinine · Chemistry
May 2021 497d
Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M
K193525 · CZP Iga, Antigen, Antiserum,... · Immunology
Jun 2020 190d
Yumizen C1200 CRP
K192028 · DCK C-reactive Protein,... · Immunology
Jun 2020 335d
Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
K191562 · DBF Ferritin, Antigen,... · Immunology
Mar 2020 267d
Yumizen C1200 CRP
K191993 · DCK C-reactive Protein,... · Chemistry
Oct 2019 70d
Yumizen C1200 ALP, Yumizen C1200 Albumin
K191245 · CJE Nitrophenylphosphate,... · Chemistry
Aug 2019 113d
Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
K191396 · CJY Azo Dye, Calcium · Chemistry
Jul 2019 63d
ABX MICROS ES 60 OT and ABX MICROS ES 60 CT
K170353 · GKZ Counter, Differential Cell · Hematology
Nov 2017 271d
PENTRA XLR
K151133 · GKZ Counter, Differential Cell · Hematology
Dec 2015 225d
ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL)
K141161 · GKZ Counter, Differential Cell · Hematology
Dec 2014 229d
ABX PENTRA MICRO ALB CONTROL L/H
K133676 · JJY Multi-analyte Controls,... · Chemistry
Jul 2014 224d
ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT
K123171 · CJY Azo Dye, Calcium · Chemistry
Jul 2013 267d
ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL
K110530 · CGX Alkaline Picrate,... · Chemistry
Apr 2012 431d
PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT
K103788 · CFR Hexokinase, Glucose · Chemistry
Nov 2011 316d
ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN
K110137 · JFY Enzymatic Method, Creatinine · Chemistry
Aug 2011 204d
ABX PENTRA TPU CAL, MODEL A11A01898
K092570 · JIT Calibrator, Secondary · Chemistry
Oct 2009 56d
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