FDA Registration
Active
🇺🇸 United States
ARK Oxcarbazepine Metabolite Calibrator
Reg #: 3005755244
·
FEI: 3005755244
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- ARK DIAGNOSTICS INC
- Registration Number
- 3005755244
- FEI Number
- 3005755244
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 48089 Fremont Blvd
- City
- Fremont
- State
- CA
- ZIP
- 94538
- Country
- US
Regulatory Submissions
- 510(k) Number
- K153596
Owner / Operator
- Firm Name
- ARK Diagnostics Inc
- Operator Number
- 10027663
- Address
- 48089 Fremont Blvd
- City
- Fremont
- State
- CA
- Postal Code
- 94538
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drug Specific Control Materials | LAS | Class 1 | Clinical Toxicology | No | 2016-08-18 |
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2016-08-18 |
| Enzyme Immunoassay, Oxcarbazepine Metabolite | POX | Class 2 | Clinical Toxicology | No | 2016-08-18 |
Proprietary Names
ARK Oxcarbazepine Metabolite Calibrator
ARK Oxcarbazepine Metabolite Assay
ARK Oxcarbazepine Metabolite Control
Establishment Types
Manufacture Medical Device