FDA Registration
Active
🇺🇸 United States
STANBIO LABORATORY
Reg #: 1616487
·
FEI: 1616487
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STANBIO LABORATORY
- Registration Number
- 1616487
- FEI Number
- 1616487
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1261 NORTH MAIN ST.
- City
- Boerne
- State
- TX
- ZIP
- 78006
- Country
- US
Regulatory Submissions
- 510(k) Number
- K110726
Owner / Operator
- Firm Name
- STANBIO LABORATORY
- Operator Number
- 1616487
- Address
- 1261 NORTH MAIN ST., --
- City
- Boerne
- State
- TX
- Postal Code
- 78006
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Colorimetry, Acetaminophen | LDP | Class 2 | Clinical Toxicology | No | 2014-02-11 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)