FDA Registration
Active
🇺🇸 United States
Smart-Well Model 1710 EZTest Incubator
Reg #: 1720309
·
FEI: 1720309
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- MESA LABORATORIES, INC.
- Registration Number
- 1720309
- FEI Number
- 1720309
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 12100 W 6th Ave
- City
- Denver
- State
- CO
- ZIP
- 80228
- Country
- US
Regulatory Submissions
- 510(k) Number
- K122362
Owner / Operator
- Firm Name
- MESA LABORATORIES, INC.
- Operator Number
- 1720309
- Address
- 12100 WEST 6TH AVE., --
- City
- Lakewood
- State
- CO
- Postal Code
- 80228
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Indicator, Biological Sterilization Process | FRC | Class 2 | General Hospital | No | 2016-07-27 |
Proprietary Names
Smart-Well Model 1710 EZTest Incubator
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device