FDA Registration
Active
🇺🇸 United States
60-BZ0268 Pointe Benzodiazepine Calibrator/Control (Oxazepam 300 ng/mL)
Reg #: 1827821
·
FEI: 1827821
·
Expires 2025
Products
3
Proprietary Names
6
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
- K032365
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 |
|---|---|---|---|---|---|
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2021-11-23 |
| Drug Specific Control Materials | LAS | Class 1 | Clinical Toxicology | No | 2021-11-23 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2021-11-23 |
Proprietary Names
60-BZ0268 Pointe Benzodiazepine Calibrator/Control (Oxazepam 300 ng/mL)
60-BZ0260 Pointe Benzodiazepine Reagent
60-BZ0266 Pointe Benzodiazepine Calibrator/Control (Oxazepam 200 ng/mL)
60-BZ0272 Pointe Benzodiazepine Control (Oxazepam 400 ng/mL)
60-BZ0264 Pointe Benzodiazepine Calibrator/Control (Oxazepam 100 ng/mL)
60-BZ0270 Pointe Benzodiazepine Calibrator (Oxazepam 1000 ng/mL)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device