Data / Medical devices / Japan / Horiba Ltd.
Horiba Ltd.: FDA-registered device maker in Kyoto, Japan, 1 510(k) clearance
Horiba Ltd. is registered with the FDA (registration 1000256526) in Kyoto, Japan. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 12, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000256526
- Address
- 2 Miyanohigashi, Kisshoin, Minami-Ku, Kyoto, Japan, 601-8510
- Owner or operator
- HORIBA LTD. (9052537)
- Roles
- Contract manufacturer, Exporter to the US, Specification developer
- First device listed
- November 7, 2002
- Registered through
- 2026
- Brand names listed
- Chloride Electrode, Cuvette Conditioner EX, Cuvette Wash Solution 7, I.S.E.MODULE, ISE Buffer (IS), ISE Detergent Solution, ISE SERUM STANDARD SET NA, ISE URINE STANDARD SET and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Contract manufacturer, Exporter to the US, Specification developer | accessdata.fda.gov |
| Calibrator, Multi-Analyte Mixture | JIX | 2 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Electrode, Ion Selective (Non-Specified) | JJP | 1 | Exporter to the US | accessdata.fda.gov |
| Electrode, Ion Specific, Potassium | CEM | 2 | Contract manufacturer, Exporter to the US, Specification developer | accessdata.fda.gov |
| Electrode, Ion Specific, Sodium | JGS | 2 | Contract manufacturer, Exporter to the US, Specification developer | accessdata.fda.gov |
| Electrode, Ion-Specific, Chloride | CGZ | 2 | Contract manufacturer, Exporter to the US, Specification developer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Exporter to the US | accessdata.fda.gov |
| Hexokinase, Glucose | CFR | 2 | Contract manufacturer, Exporter to the US, Specification developer | accessdata.fda.gov |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 12, 2019 | K183375 | Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode | JJE | Substantially Equivalent | Horiba, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Calibrator, Multi-Analyte Mixture
- All makers of Electrode, Ion Selective (Non-Specified)
- All makers of Electrode, Ion Specific, Sodium
- All makers of Electrode, Ion Specific, Potassium
- All makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- All makers of Electrode, Ion-Specific, Chloride
Updated February 12, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.