FDA Registration
Active
🇺🇸 United States
EZTest Biological Test Pack for Use in Steam Sterilizers
Reg #: 3013667284
·
FEI: 3013667284
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Mesa Laboratories Bozeman Manufacturing Facility (Zoot)
- Registration Number
- 3013667284
- FEI Number
- 3013667284
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 625 Zoot Way
- City
- Bozeman
- State
- MT
- ZIP
- 59718
- Country
- US
Regulatory Submissions
- 510(k) Number
- K001444
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, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2018-12-04 |
Proprietary Names
EZTest Biological Test Pack for Use in Steam Sterilizers
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198