510(k) Report

FDA applicant

Horiba Abx

Montpellier, FR37 decisions2005–202621 recalls

FDA records 37 decisions for Horiba Abx (Montpellier, FR) from 2005 to 2026: 37 510(k) clearances. Most are in product codes GKZ (Counter, Differential Cell) and DCK (C-Reactive Protein, Antigen, Antiserum, And…). Since 2016 its 510(k)s took a median of 244 days from receipt to decision, against 254 for FDA’s reviews in the same codes and years. Its devices cite 95 predicates, 20 of them its own earlier devices. 21 recalls are linked to its devices.

FDA’s records also spell it “HORIBA ABX SAS”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Horiba Abx’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007: 52008: 32009: 12011: 22012: 12013: 12014: 22015: 12017: 12019: 32020: 32021: 12024: 12026 (partial year): 1
2007high 5 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2022

2012: 32013: 42014: 42016: 52017: 22021: 12022: 1
2007high 5 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Horiba Abx by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Horiba Abx’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GKZCounter, Differential Cell7decisions
  • DCKC-Reactive Protein, Antigen, Antiserum, And Control3decisions
  • CFRHexokinase, Glucose3decisions
  • CGXAlkaline Picrate, Colorimetry, Creatinine2decisions
  • CJYAzo Dye, Calcium2decisions
  • JITCalibrator, Secondary2decisions

Also: JFY (2), CJE (2), CDQ (1), CIG (1), JIX (1), JFJ (1).

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 244 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 254 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 95 predicates; 20 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 35 times; 20 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K052007Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Horiba Abx · 20059cite it
  • K070249Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine Control L/HHoriba Abx · 20076cite it
  • K060854Abx Pentra 400: LipoproteinsHoriba Abx · 20063cite it
  • K070146Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPHoriba Abx · 20072cite it
  • K060325Abx Pentra Bilirubin, Direct CP, Abx Pentra Bilirubin, Total CP, Abx Pentra Multical, Abx Pentra N Control…Horiba Abx · 20062cite it
  • K060318Hepatic Enzymes on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 20062cite it

What has FDA decided for it lately?

  • K260781Yumizen H550Horiba Abx Sas · 2026
  • K232946Yumizen H2500Horiba Abx Sas · 2024
  • K193649Yumizen C1200 Creatinine PAPHoriba Abx Sas · 2021
  • K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin MHoriba Abx Sas · 2020
  • K192028Yumizen C1200 CRPHoriba Abx Sas · 2020
  • K191562Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactorHoriba Abx Sas · 2020
  • K191993Yumizen C1200 CRPHoriba Abx Sas · 2019
  • K191245Yumizen C1200 ALP, Yumizen C1200 AlbuminHoriba Abx Sas · 2019

All 19 as Horiba Abx →All 18 as Horiba Abx Sas →

What has been recalled?

21 recalls linked to its devices; the latest:

  • K110530a. ABX PENTRA CREATININE 120CP JAFFE 120/130. Ref: A11A01933. b. Reagent General…May 25, 2022Class II
  • K060205ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954Oct 22, 2021Class II
  • K05200715 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400Nov 21, 2017Class II
  • K05200710 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400Nov 21, 2017Class II
  • K052007ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in…Jan 11, 2016Class II
  • K060854ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the…Jan 11, 2016Class II

Other applicant names beginning “Horiba”

FDA records each applicant name separately; these may or may not be the same firm.

Horiba Instruments, Inc. 5Horiba, Ltd. 2