Company ยท US
Mesa Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2020. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 2, 2020 | K201765 | SmartHDM-510 System Mesa Laboratories, Inc. | FIZ |
| Aug 5, 2019 | K191496 | TDS Standard Solution Mesa Laboratories, Inc. | FKH |
| Sep 21, 2015 | K150657 | Phoenix XL Dialysate Meter Mesa Laboratories, Inc. | FIZ |
| Dec 3, 2014 | K140589 | STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR Mesa Laboratories, Inc. | FRC |
| Apr 18, 2013 | K130100 | COMINED STANDARD SOLUTION Mesa Laboratories, Inc. | FKH |
| Mar 26, 2013 | K122362 | SMART-WELL INCUBATOR Mesa Laboratories, Inc. | FRC |
| Jan 30, 2012 | K112018 | SMART READ EZTEST STEAM Mesa Laboratories, Inc. | FRC |
| May 5, 2005 | K050812 | 90XL INSTRUMENTATION SYSTEM Mesa Laboratories, Inc. | FIZ |
| Feb 27, 2004 | K033330 | CONDUCTIVITY/TDS CALIBRATOR SOLUTION Mesa Laboratories, Inc. | FKH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2017 | Mesa Laboratories, Inc. MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Product No. : 02.0027, 020510 (carton of 6 of 02.0027). Polyethylene bottle
Conductivity/TDS Calibrator solutions are a second Terminated |
FKH | K033330 |
| Apr 4, 2016 | Mesa Laboratories Inc ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box.
Product Usage:
Biological indicator f Terminated |
FRC | K971432 |
| Nov 7, 2013 | Mesa Laboratories, Inc. pH 7.0 Buffer Solution Pint and Quart Bottles, Part Number 02.0030 for Pints and 02.0031 for Quarts. Packaged in Plastic Bottles. Can be sold individually or in cartons with 6 bottles per box (for qu Terminated |
JCC | None listed |