FDA Registration
Active
🇺🇸 United States
Siemens Urin-Tek¿ Urine Collection System
Reg #: 3007135420
·
FEI: 3007135420
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
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
- K031947
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 |
|---|---|---|---|---|---|
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2013-12-13 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2013-12-13 |
| Test, Creatinine, Over The Counter | NFZ | Class 2 | Clinical Chemistry | No | 2013-12-13 |
Proprietary Names
Siemens Urin-Tek¿ Urine Collection System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)