FDA Registration
Active
🇺🇸 United States
D-10 Hemoglobin A1c Program
Reg #: 2915274
·
FEI: 2915274
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Bio-Rad Laboratories, Inc.
- Registration Number
- 2915274
- FEI Number
- 2915274
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 4000 Alfred Nobel Drive
- City
- Hercules
- State
- CA
- ZIP
- 94547
- Country
- US
Regulatory Submissions
- 510(k) Number
- K161687
Owner / Operator
- Firm Name
- Bio-Rad Laboratories, Inc.
- Operator Number
- 9929003
- Address
- 4000 Alfred Nobel Drive, --
- City
- Hercules
- State
- CA
- Postal Code
- 94547
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hemoglobin A1c Test System | PDJ | Class 2 | Clinical Chemistry | No | 2016-12-09 |
Proprietary Names
D-10 Hemoglobin A1c Program
Establishment Types
Manufacture Medical Device