FDA Registration
Active
🇺🇸 United States
at Home
Reg #: 2031229
·
FEI: 3000719950
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- PHAMATECH INC.
- Registration Number
- 2031229
- FEI Number
- 3000719950
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 15175 Innovation Dr
- City
- San Diego
- State
- CA
- ZIP
- 92128
- Country
- US
Regulatory Submissions
- 510(k) Number
- K070009
Owner / Operator
- Firm Name
- PHAMATECH INC.
- Operator Number
- 9026390
- Address
- 15175 Innovation Drive, --
- City
- San Diego
- State
- CA
- Postal Code
- 92128
- Country
- US
- Correspondent
- Tuan H Pham
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2008-11-20 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2008-11-20 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2008-11-20 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2008-11-20 |
Proprietary Names
at Home
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device