FDA Registration
Active
🇺🇸 United States
Advia Reaction Cuvette
Reg #: 2530112
·
FEI: 1000221217
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Carclo Technical Plastics - Export
- Registration Number
- 2530112
- FEI Number
- 1000221217
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6009 Enterprise Drive
- City
- Export
- State
- PA
- ZIP
- 15632
- Country
- US
Regulatory Submissions
- 510(k) Number
- K902336
Owner / Operator
- Firm Name
- CARCLO TECHNICAL PLASTICS
- Operator Number
- 9020456
- Address
- 600 DEPOT ST., --
- City
- Latrobe
- State
- PA
- Postal Code
- 15650
- Country
- US
- Correspondent
- Brian Kochanski
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2008-12-24 |
Proprietary Names
Advia Reaction Cuvette
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)