FDA Registration
Active
🇨🇭 Switzerland
ACCELERATOR a3600
Reg #: 3010825766
·
FEI: 3010825766
·
Expires 2025
Products
5
Proprietary Names
4
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- INPECO SA
- Registration Number
- 3010825766
- FEI Number
- 3010825766
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Via Torraccia 26
- City
- Novazzano Ticino
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K121012
Owner / Operator
- Firm Name
- Inpeco SA
- Operator Number
- 10047217
- Address
- Via Torraccia, 26
- City
- Novazzano
- State
- Ticino
- Postal Code
- 6883
- Country
- CH
- Correspondent
- Matteo Orlandi
US Agent
- Business Name
- THEMA CORP
- Contact Name
- Silvia Tamarri
- Address
- 2929 Arch Street
- City
- Philadelphia
- State
- PA
- ZIP
- 19104
- Country
- US
- [email protected]
- Phone
- 215 8459459
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2014-07-22 |
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2014-07-22 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2014-07-22 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2014-07-22 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2014-07-22 |
Proprietary Names
ACCELERATOR a3600
FlexLab, Several Models
Aptio Automation
FlexLab X
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility