FDA Registration
Active
🇺🇸 United States
60-TH0004 Pointe THC Negative Calibrator (0 ng/mL)
Reg #: 1827821
·
FEI: 1827821
·
Expires 2025
Products
3
Proprietary Names
14
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
- K110239
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 |
|---|---|---|---|---|---|
| Drug Specific Control Materials | LAS | Class 1 | Clinical Toxicology | No | 2021-11-23 |
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2021-11-23 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2021-11-23 |
Proprietary Names
60-TH0004 Pointe THC Negative Calibrator (0 ng/mL)
60-TH0148 Pointe THC Control (31.25 ng/mL)
60-TH0158 Pointe THC Calibrator (200 ng/mL)
60-TH0152 Pointe THC Calibrator/Control (75 ng/mL)
60-TH0156 Pointe THC Calibrator (150 ng/mL)
60-TH0150 Pointe THC Calibrator (50 ng/mL)
60-CA0140 Pointe Cannabinoid (THC) Reagent
60-TH0144 Pointe THC Calibrator (12.5 ng/mL)
60-TH0014 Pointe THC Calibrator/Control (37.5 ng/mL)
60-TH0146 Pointe THC Calibrator (25 ng/mL)
60-TH0012 Pointe THC Control (18.75 ng/mL)
60-TH0016 Pointe THC Control (62.5 ng/mL)
60-TH0154 Pointe THC Calibrator (100 ng/mL)
60-TH0018 Pointe THC Control (125 ng/mL)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device