FDA Registration
Active
🇺🇸 United States
HM929, Pointe Magnesium Reagent
Reg #: 1827821
·
FEI: 1827821
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HORIBA INSTRUMENTS INCORPORATED
- Registration Number
- 1827821
- FEI Number
- 1827821
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5449 RESEARCH DRIVE
- City
- Canton Twp
- State
- MI
- ZIP
- 48188
- Country
- US
Regulatory Submissions
- 510(k) Number
- K853592
Owner / Operator
- Firm Name
- HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical
- Operator Number
- 10083022
- Address
- 9755 Research Drive
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Photometric Method, Magnesium | JGJ | Class 1 | Clinical Chemistry | No | 2021-11-22 |
Proprietary Names
HM929, Pointe Magnesium Reagent
M7527-STD, Pointe Magnesium Standard
Establishment Types
Manufacture Medical Device