FDA Registration
Active
🇯🇵 Japan
ISE SERUM STANDARD SET NA
Reg #: 1000256526
·
FEI: 1000256526
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
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
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 |
|---|---|---|---|---|---|
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2020-11-30 |
Proprietary Names
ISE SERUM STANDARD SET NA
ISE URINE STANDARD SET
Internal Standard
Establishment Types
Export Device to the United States But Perform No Other Operation on Device