FDA Registration
Active
🇺🇸 United States
MESA LABORATORIES, INC.
Reg #: 1720309
·
FEI: 1720309
·
Expires 2026
Products
6
Proprietary Names
11
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- MESA LABORATORIES, INC.
- Registration Number
- 1720309
- FEI Number
- 1720309
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 12100 W 6th Ave
- City
- Denver
- State
- CO
- ZIP
- 80228
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191496
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 |
|---|---|---|---|---|---|
| Ph Buffer | JCC | Class 1 | Pathology | No | 1992-06-18 |
| Solution-Test Standard-Conductivity, Dialysis | FKH | Class 2 | Gastroenterology, Urology | No | 2020-04-16 |
| Meter, Conductivity, Non-Remote | FIZ | Class 2 | Gastroenterology, Urology | No | 2010-05-17 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 1992-06-18 |
| Indicator, Biological Sterilization Process | FRC | Class 2 | General Hospital | No | 2016-07-27 |
| Subsystem, Water Purification | FIP | Class 2 | Gastroenterology, Urology | No | 2010-05-17 |
Proprietary Names
PH BUFFER SOLUTIONS
TDS Standard Solution
PHOENIX DIALYSATE METER
90XL INSTRUMENTATION SYSTEM
HDM97
Conductivity Standard Solution
MONITORING LINE
Smart-Well Model 1710 EZTest Incubator
SMART-WELL EZTEST INCUBATOR
NEO-STAT DIALYSATE METER
HYDRA METER
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device