FDA Registration
Active
🇯🇵 Japan
I.S.E.MODULE
Reg #: 1000256526
·
FEI: 1000256526
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- HORIBA LTD.
- Registration Number
- 1000256526
- FEI Number
- 1000256526
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2 MIYANOHIGASHI, KISSHOIN,, MINAMI-KU
- City
- KYOTO
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K052007
Owner / Operator
- Firm Name
- HORIBA LTD.
- Operator Number
- 9052537
- Address
- 2 MIYANOHIGASHI, KISSHOIN,, MINAMI-KU
- City
- KYOTO
- State
- JP-26
- Postal Code
- 601-8510
- Country
- JP
- Correspondent
- JUNYA - OKETANI
US Agent
- Business Name
- HORIBA Instruments Incorporated
- Contact Name
- Will Cripps
- Address
- 5449 Research Drive, Canton, MI 48188
- City
- Canton
- State
- MI
- ZIP
- 48188
- Country
- US
- [email protected]
- Phone
- 800 4459853
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2018-02-01 |
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2018-02-01 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2018-02-01 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2018-02-01 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2018-02-01 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2018-02-01 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2018-02-01 |
Proprietary Names
I.S.E.MODULE
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)