FDA Registration
Active
🇺🇸 United States
Pointe C2000 Chemistry Analyzer
Reg #: 1827821
·
FEI: 1827821
·
Expires 2025
Products
5
Proprietary Names
2
Establishment Types
2
Classifications
5
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
- K072018
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 |
|---|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2021-11-23 |
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2021-11-23 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2021-11-23 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2021-11-23 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2021-11-23 |
Proprietary Names
Pointe C2000 Chemistry Analyzer
Mindray BS200 Chemistry Analyzer
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198