Horiba Abx: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Horiba Abx” (first 2005, latest 2008), across 17 product codes in 3 review panels. Median 510(k) review time under this name: 158 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CFR | Hexokinase, Glucose | 2 | 2 |
| GKZ | Counter, Differential Cell | 2 | 2 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
Plus 7 more product codes.
Review panels
- Clinical Chemistry (13)
- Hematology (5)
- Immunology (1)
Most recent Horiba Abx 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K073309 | ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT | LCP | 2008-10-17 | 329 |
| K081276 | ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H | CFR | 2008-09-12 | 130 |
| K071779 | ABX PENTRA URINE CAL | JIX | 2008-03-05 | 247 |
| K072115 | ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H | CGX | 2007-11-30 | 121 |
| K070146 | ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP | CDQ | 2007-10-12 | 269 |
| K062737 | CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER | CGS | 2007-06-12 | 272 |
| K060434 | ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL | CIX | 2007-06-05 | 469 |
| K070249 | ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H | CIC | 2007-04-26 | 90 |
| K062180 | ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP | JFJ | 2006-10-02 | 63 |
| K061138 | ABX PENTRA 400 : CRP | DCK | 2006-09-29 | 158 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Horiba Abx.
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 SAS (18 510(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?
FDA lists 19 510(k) clearances under the applicant name “Horiba Abx” (first 2005, latest 2008), across 17 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?
The median time from FDA receipt to decision across 510(k)s cleared under the name Horiba Abx is 158 days.
Which FDA product codes appear under Horiba Abx?
The most frequent FDA product codes under this applicant name are CFR (Hexokinase, Glucose, 2); GKZ (Counter, Differential Cell, 2); CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen, 1).
Next steps
- See all 19 Horiba Abx clearances with predicates and recalls
- Run predicate analysis for product code CFR, Horiba Abx'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.