FDA Registration
Active
🇺🇸 United States
XN CAL PF
Reg #: 1950302
·
FEI: 1950302
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STRECK LLC
- Registration Number
- 1950302
- FEI Number
- 1950302
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 7002 SOUTH 109TH ST.
- City
- La Vista
- State
- NE
- ZIP
- 68128
- Country
- US
Regulatory Submissions
- 510(k) Number
- K141955
Owner / Operator
- Firm Name
- STRECK
- Operator Number
- 1950302
- Address
- 7002 SOUTH 109TH ST., --
- City
- La Vista
- State
- NE
- Postal Code
- 68128
- Country
- US
- Correspondent
- Wendy - Royalty
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Calibrator For Cell Indices | KRX | Class 2 | Hematology | No | 2014-12-23 |
Proprietary Names
XN CAL PF
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)