Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013667284

FEI Number

3013667284

Entity Name

Mesa Laboratories Bozeman Manufacturing Facility (Zoot)

City/State/Country

Bozeman, MT, US

Establishment Address

625 Zoot Way, Bozeman, MT 59718, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

MESA LABORATORIES, INC. (Owner Number: 1720309)

Owner / Operator Contact Address

12100 WEST 6TH AVE., --, Lakewood, CO 80228, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K103000

PMA Number

N/A

All Registered Proprietary Names

Smart-Read EZTest Biological Indicator Monitoring System Smart-Read EZTest Indicatore Biologico Auto-Contenuto ExpoSure Steam EZTest Biological Test Pack for Use in Steam Sterilizers ProChem EXT Spore Strip Biological Indicator EO/Dry Heat EZTest Indicatore Biologico Auto-Contenuto Getinge Assured Biological Indicators for Steam Sterilization EZTest Biological Indicator for Steam Sterilization Exposure Biological Indicator ProSpore Biological Indicator Mesa ProChem B-D 121 Bowie-Dick Test Pack Mesa ProChem B-D Test Pack Mesa Dry Heat Indicator Labels Smart-Read EZTest Steam Biological Test Pack with Instant Readout Integrator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2011-07-21
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2018-12-04
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2008-10-06
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2016-08-29
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2011-07-21
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2016-08-25
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2018-11-14
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2018-11-14
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2017-03-28
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2018-11-14
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2018-12-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MESA LABORATORIES, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003884198	IBP MEDICAL GMBH	HANNOVER Lower Saxony, DE
1720309	MESA LABORATORIES, INC.	Denver, CO, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K151482	Bcr Diagnostics, Inc.	BCR-30-min BI and RBIP-ST30 Readout Accessory	2016-02-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013667284. Last updated year: 2026. Please use registration number 3013667284 when referencing this establishment in official correspondence.