Mesa Laboratories, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 9
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2159-2017 | Class II | MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Product No. : 02.0027, 02051 | May 12, 2017 |
| Z-1104-2017 | Class II | ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearotherm | April 4, 2016 |
| Z-0175-2014 | Class II | pH 7.0 Buffer Solution Pint and Quart Bottles, Part Number 02.0030 for Pints and 02.0031 for Quarts. | September 13, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K201765 | SmartHDM-510 System | September 2, 2020 |
| K191496 | TDS Standard Solution | August 5, 2019 |
| K150657 | Phoenix XL Dialysate Meter | September 21, 2015 |
| K140589 | STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR | December 3, 2014 |
| K130100 | COMINED STANDARD SOLUTION | April 18, 2013 |
| K122362 | SMART-WELL INCUBATOR | March 26, 2013 |
| K112018 | SMART READ EZTEST STEAM | January 30, 2012 |
| K050812 | 90XL INSTRUMENTATION SYSTEM | May 5, 2005 |
| K033330 | CONDUCTIVITY/TDS CALIBRATOR SOLUTION | February 27, 2004 |