Data / Medical devices / United States / Mesa Laboratories, Inc.
Mesa Laboratories, Inc.: FDA-registered device maker in Denver, CO, United States, 9 510(k) clearances
Mesa Laboratories, Inc. is registered with the FDA (registration 1720309) in Denver, CO, United States. It lists 6 device types. The FDA files 9 510(k) clearances under its listings, the newest dated August 5, 2019. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1720309
- Address
- 12100 W 6th Ave, Denver, CO, United States, 80228
- Owner or operator
- MESA LABORATORIES, INC. (1720309)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- June 18, 1992
- Registered through
- 2026
- Brand names listed
- 90XL INSTRUMENTATION SYSTEM, Conductivity Standard Solution, HDM97, HYDRA METER, MONITORING LINE, PH BUFFER SOLUTIONS, SMART-WELL EZTEST INCUBATOR, Smart-Well Model 1710 EZTest Incubator and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Indicator, Biological Sterilization Process | FRC | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Meter, Conductivity, Non-Remote | FIZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Ph Buffer | JCC | 1 | Manufacturer | accessdata.fda.gov |
| Solution-Test Standard-Conductivity, Dialysis | FKH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Subsystem, Water Purification | FIP | 2 | Manufacturer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 5, 2019 | K191496 | TDS Standard Solution | FKH | Substantially Equivalent | Mesa Laboratories, Inc. | accessdata.fda.gov |
| September 21, 2015 | K150657 | Phoenix XL Dialysate Meter | FIZ | Substantially Equivalent | Mesa Laboratories, Inc. | accessdata.fda.gov |
| April 18, 2013 | K130100 | COMINED STANDARD SOLUTION | FKH | Substantially Equivalent | Mesa Laboratories, Inc. | accessdata.fda.gov |
| March 26, 2013 | K122362 | SMART-WELL INCUBATOR | FRC | Substantially Equivalent | Mesa Laboratories, Inc. | accessdata.fda.gov |
| January 15, 2010 | K091950 | SMART-WELL EZTEST INCUBATOR | FRC | Substantially Equivalent | Sgm Biotech, Inc. | accessdata.fda.gov |
| May 5, 2005 | K050812 | 90XL INSTRUMENTATION SYSTEM | FIZ | Substantially Equivalent | Mesa Laboratories, Inc. | accessdata.fda.gov |
| February 27, 2004 | K033330 | CONDUCTIVITY/TDS CALIBRATOR SOLUTION | FKH | Substantially Equivalent | Mesa Laboratories, Inc. | accessdata.fda.gov |
| May 22, 2002 | K020908 | HDM97 | FIZ | Substantially Equivalent | Ibp Instruments GmbH | accessdata.fda.gov |
| December 19, 1997 | K974127 | HYDRA METER | FIP | Substantially Equivalent | Automata Instrumentation, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 12, 2017 | 77290 | Class II | Terminated | 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 secondary standard solution u | Mesa Laboratories is recalling Conductivity/TDS Calibrator Solution due to failure to meet product specifications. | accessdata.fda.gov |
| September 13, 2013 | 66475 | Class II | Terminated | 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 quart bottles only). Us | Mesa Laboratories, Inc. is recalling certain lots of pH 7.0 Buffer Solution due to mold growth. | accessdata.fda.gov |
Compare with other makers
- All makers of Solution-Test Standard-Conductivity, Dialysis
- All makers of Tubing, Pressure And Accessories
- All makers of Indicator, Biological Sterilization Process
- All makers of Ph Buffer
- All makers of Subsystem, Water Purification
Updated August 5, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.