HORIBA ABX SAS: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “HORIBA ABX SAS” (first 2009, latest 2026), across 11 product codes in 3 review panels. Median 510(k) review time under this name: 227 days. Since 2017 the median was 217 days, against 203 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 431 |
| 2013 | 1 | 267 |
| 2014 | 2 | 226 |
| 2015 | 1 | 225 |
| 2016 | 0 | — |
| 2017 | 1 | 271 |
| 2018 | 0 | — |
| 2019 | 3 | 70 |
| 2020 | 3 | 267 |
| 2021 | 1 | 497 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 244 |
| 2025 | 0 | — |
| 2026 | 1 | 188 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name HORIBA ABX SAS took a median 217 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 203 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GKZ | Counter, Differential Cell | 5 | 5 |
| CJY | Azo Dye, Calcium | 2 | 2 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 2 | 2 |
| JFY | Enzymatic Method, Creatinine | 2 | 2 |
| CFR | Hexokinase, Glucose | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
| CZP | Iga, Antigen, Antiserum, Control | 1 | 1 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 | 1 |
| JIT | Calibrator, Secondary | 1 | 1 |
Plus 1 more product codes.
Review panels
- Clinical Chemistry (9)
- Hematology (5)
- Immunology (4)
Most recent HORIBA ABX SAS 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260781 | Yumizen H550 | GKZ | 2026-09-14 | 188 |
| K232946 | Yumizen H2500 | GKZ | 2024-05-21 | 244 |
| K193649 | Yumizen C1200 Creatinine PAP | JFY | 2021-05-10 | 497 |
| K193525 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M | CZP | 2020-06-26 | 190 |
| K192028 | Yumizen C1200 CRP | DCK | 2020-06-25 | 335 |
| K191562 | Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor | DBF | 2020-03-06 | 267 |
| K191993 | Yumizen C1200 CRP | DCK | 2019-10-03 | 70 |
| K191245 | Yumizen C1200 ALP, Yumizen C1200 Albumin | CJE | 2019-08-30 | 113 |
| K191396 | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe | CJY | 2019-07-26 | 63 |
| K170353 | ABX MICROS ES 60 OT and ABX MICROS ES 60 CT | GKZ | 2017-11-01 | 271 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named HORIBA ABX SAS.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Horiba Abx (19 510(k)s)
- Horiba Instruments, Inc. (5 510(k)s)
- Horiba, Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under HORIBA ABX SAS?
FDA lists 18 510(k) clearances under the applicant name “HORIBA ABX SAS” (first 2009, latest 2026), across 11 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by HORIBA ABX SAS?
The median time from FDA receipt to decision across 510(k)s cleared under the name HORIBA ABX SAS is 227 days. Since 2017: 217 days, versus 203 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under HORIBA ABX SAS?
The most frequent FDA product codes under this applicant name are GKZ (Counter, Differential Cell, 5); CJY (Azo Dye, Calcium, 2); DCK (C-Reactive Protein, Antigen, Antiserum, And Control, 2).
Next steps
- See all 18 HORIBA ABX SAS clearances with predicates and recalls
- Run predicate analysis for product code GKZ, HORIBA ABX SAS's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.