FDA Registration
Active
🇺🇸 United States
microdot
Reg #: 3008700497
·
FEI: 3008700497
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Cambridge Sensors USA, LLC.
- Registration Number
- 3008700497
- FEI Number
- 3008700497
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 23866 W Industrial Dr N
- City
- Plainfield
- State
- IL
- ZIP
- 60585
- Country
- US
Regulatory Submissions
- 510(k) Number
- K032076
Owner / Operator
- Firm Name
- Cambridge Sensors USA, LLC.
- Operator Number
- 10042320
- Address
- 23866 W Industrial Drive N
- City
- Plainfield
- State
- IL
- Postal Code
- 60585
- Country
- US
- Correspondent
- Chris W Sullivan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2012-11-14 |
Proprietary Names
microdot
Establishment Types
Complaint File Establishment per 21 CFR 820.198