FDA Registration
Active
🇺🇸 United States
Carclo Technical Plastics - Latrobe
Reg #: 3007135420
·
FEI: 3007135420
·
Expires 2025
Products
6
Proprietary Names
0
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Carclo Technical Plastics - Latrobe
- Registration Number
- 3007135420
- FEI Number
- 3007135420
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 600 Depot St
- City
- Latrobe
- State
- PA
- ZIP
- 15650
- Country
- US
Regulatory Submissions
- 510(k) Number
- K970227
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 | 2008-05-15 |
| Radioimmunoassay, Immunoglobulins (D, E) | JHR | Class 2 | Immunology | No | 2008-05-15 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2008-05-15 |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | Class 1 | Clinical Chemistry | No | 2008-05-15 |
| System, Test, Radioallergosorbent (Rast) Immunological | DHB | Class 2 | Immunology | No | 2008-05-15 |
| Enzyme Immunoassay, Theophylline | KLS | Class 2 | Clinical Toxicology | No | 2008-05-15 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)