FDA Registration
Active
🇺🇸 United States
LPA400C Lipoprotein (a) Calibrator
Reg #: 1827821
·
FEI: 1827821
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
2
Classifications
3
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
- K011568
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 |
|---|---|---|---|---|---|
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2022-06-01 |
| Controls For Blood-Gases, (Assayed And Unassayed) | JJS | Class 1 | Clinical Chemistry | No | 2022-06-01 |
| Lipoprotein, Low-Density, Antigen, Antiserum, Control | DFC | Class 2 | Immunology | No | 2022-06-01 |
Proprietary Names
LPA400C Lipoprotein (a) Calibrator
LPA400 Lipoprotein (a)
LPA400CR Lipoprotein (a) Calibrator
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device