Data / Medical devices / United States / Mesa Laboratories Bozeman Manufacturing Facility (Zoot)
Mesa Laboratories Bozeman Manufacturing Facility (Zoot): FDA-registered device maker in Bozeman, MT, United States, 13 510(k) clearances
Mesa Laboratories Bozeman Manufacturing Facility (Zoot) is registered with the FDA (registration 3013667284) in Bozeman, MT, United States. It lists 2 device types. The FDA files 13 510(k) clearances under its listings, the newest dated May 12, 2016. 3 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
- 3013667284
- Address
- 625 Zoot Way, Bozeman, MT, United States, 59718
- Owner or operator
- MESA LABORATORIES, INC. (1720309)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- June 29, 1992
- Registered through
- 2026
- Brand names listed
- EZTest Biological Indicator for EO Sterilization, EZTest Biological Indicator for Steam Sterilization, EZTest Biological Test Pack for Use in Steam Sterilizers, EZTest Indicatore Biologico Auto-Contenuto, EZTest Indicatore Biologico Auto-Contenuto per Sterilizzazione ad ossido di etilene, ExpoSure Steam, Exposure Biological Indicator, Getinge Assured Biological Indicators for Steam Sterilization and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Indicator, Biological Sterilization Process | FRC | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | 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 |
|---|---|---|---|---|---|---|
| May 12, 2016 | K152630 | VERIFY STEAM Integrating Indicator | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| December 3, 2014 | K140589 | STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR | FRC | Substantially Equivalent | Mesa Laboratories, Inc. | accessdata.fda.gov |
| February 11, 2011 | K103000 | SMART READ BIOLOGICAL TEST PACK | JOJ | Substantially Equivalent | Steritec Products Mfg Co, Inc. | accessdata.fda.gov |
| May 14, 2010 | K093794 | SMART-READ EZTEST-STEAM SCBI AND TEST PACK | FRC | Substantially Equivalent | Sgm Biotech, Inc. | accessdata.fda.gov |
| March 15, 2007 | K062651 | PROCHEM EXT CHEMICAL INTEGRATOR | JOJ | Substantially Equivalent | Raven Biological Laboratories, Inc. | accessdata.fda.gov |
| March 23, 2005 | K050591 | MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS | FRC | Substantially Equivalent | Raven Biological Laboratories, Inc. | accessdata.fda.gov |
| May 25, 2004 | K032914 | MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS | FRC | Substantially Equivalent | Raven Biological Laboratories, Inc. | accessdata.fda.gov |
| May 15, 2000 | K001444 | STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103 | JOJ | Substantially Equivalent | Steritec Products, Inc. | accessdata.fda.gov |
| June 10, 1999 | K990246 | STERI-PAK LF BOWIE-DICK TEST PACK | JOJ | Substantially Equivalent | Steritec Products Mfg Co, Inc. | accessdata.fda.gov |
| May 20, 1997 | K971432 | PROSPORE | FRC | Substantially Equivalent | Raven Biological Laboratories, Inc. | accessdata.fda.gov |
| April 2, 1997 | K953122 | STERITEC DRY HEAT INDICATOR LABEL | JOJ | Substantially Equivalent | Steritec Products Mfg Co, Inc. | accessdata.fda.gov |
| March 4, 1997 | K930683 | EZTEST-GAS | FRC | Substantially Equivalent | Sgm Biomedical, Inc. | accessdata.fda.gov |
| April 4, 1994 | K930682 | EZTEST-STEAM | FRC | Substantially Equivalent | Sgm Biotech, 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 |
|---|---|---|---|---|---|---|
| February 12, 2018 | 79374 | Class II | Terminated | ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471 | The concentration of bromocresol purple in the recalled lots does not conform to specification. | accessdata.fda.gov |
| April 4, 2016 | 76101 | Class II | Terminated | 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 for steam sterilization | Product resistance has fallen outside of label claim within expiry. | accessdata.fda.gov |
| June 4, 2013 | 65544 | Class II | Terminated | Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes. | Mesa EZTest, Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims. | accessdata.fda.gov |
Compare with other makers
- All makers of Indicator, Biological Sterilization Process
- All makers of Indicator, Physical/Chemical Sterilization Process
Updated May 12, 2016. 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.