Mesa Laboratories, Inc.
Medical device manufacturer in Lakewood, CO.
9510(k) clearances
0PMA approvals
3recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K201765 | SmartHDM-510 SystemFIZ · Special | 09/02/2020SE |
| K191496 | TDS Standard SolutionFKH · Traditional | 08/05/2019SE |
| K150657 | Phoenix XL Dialysate MeterFIZ · Traditional | 09/21/2015SE |
| K140589 | Sterrad Cyclesure 24 Plus Biological IndicatorFRC · Traditional | 12/03/2014SE |
| K130100 | Comined Standard SolutionFKH · Traditional | 04/18/2013SE |
| K122362 | Smart-Well IncubatorFRC · Special | 03/26/2013SE |
| K112018 | Smart Read Eztest SteamFRC · Traditional | 01/30/2012SE |
| K050812 | 90XL Instrumentation SystemFIZ · Special | 05/05/2005SE |
| K033330 | Conductivity/Tds Calibrator SolutionFKH · Traditional | 02/27/2004SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2159-2017 Class II | MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Product No. :…Mesa Laboratories is recalling Conductivity/TDS Calibrator Solution due to failure to meet product… | 05/12/2017Terminated |
| Z-1104-2017 Class II | ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus…Product resistance has fallen outside of label claim within expiry. | 04/04/2016Terminated |
| Z-0175-2014 Class II | pH 7.0 Buffer Solution Pint and Quart Bottles, Part Number 02.0030 for Pints and 02.0031…Mesa Laboratories, Inc. is recalling certain lots of pH 7.0 Buffer Solution due to mold growth. | 09/13/2013Terminated |