FDA Registration
Active
🇺🇸 United States
Atellica CH Dilution Cuvette Segment
Reg #: 1317202
·
FEI: 1317202
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TESSY PLASTICS CORP.
- Registration Number
- 1317202
- FEI Number
- 1317202
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 488 ROUTE 5 WEST
- City
- ELBRIDGE
- State
- NY
- ZIP
- 13060
- Country
- US
Regulatory Submissions
- 510(k) Number
- K161954
Owner / Operator
- Firm Name
- TESSY PLASTICS CORP.
- Operator Number
- 1317202
- Address
- 488 ROUTE 5 WEST, --
- City
- Elbridge
- State
- NY
- Postal Code
- 13060
- Country
- US
- Correspondent
- ERIKA - FIELD
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2024-06-18 |
Proprietary Names
Atellica CH Dilution Cuvette Segment
Atellica CH Reaction Cuvette Segment
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)