FDA Registration
Active
🇺🇸 United States
2300 StatPlus
Reg #: 1550101
·
FEI: 1550101
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- YSI INCORPORATED
- Registration Number
- 1550101
- FEI Number
- 1550101
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1700 BRANNUM LN # 1725
- City
- Yellow Spgs
- State
- OH
- ZIP
- 45387
- Country
- US
Regulatory Submissions
- 510(k) Number
- K913806
Owner / Operator
- Firm Name
- YSI INCORPORATED
- Operator Number
- 1550101
- Address
- 1725 BRANNUM LN., --
- City
- Yellow Springs
- State
- OH
- Postal Code
- 45387
- Country
- US
- Correspondent
- ERIC LUTE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2022-12-12 |
Proprietary Names
2300 StatPlus
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device