Mesa Laboratories Bozeman Manufacturing Facility Zoot

FDA Filings

This page includes the latest FDA filings for Mesa Laboratories Bozeman Manufacturing Facility Zoot. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3013667284
• FEI Number: 3013667284
• Name: Mesa Laboratories Bozeman Manufacturing Facility (Zoot)
• Owner & Operator: MESA LABORATORIES, INC.
• Contact Address: 12100 WEST 6TH AVE. --; Lakewood CO 80228 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 625 Zoot Way ; Bozeman, MT 59718 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K103000 | JOJ Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]	Smart-Read EZTest Steam Biological Test Pack with Instant Readout Integrator	2018-12-04
PMN K001444 | JOJ Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]	EZTest Biological Test Pack for Use in Steam Sterilizers	2018-12-04
PMN K990246 | JOJ Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]	Mesa ProChem B-D Test Pack	2018-11-14
PMN K990246 | JOJ Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]	Mesa ProChem B-D 121 Bowie-Dick Test Pack	2018-11-14
PMN K971432 | FRC Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]	ProSpore Biological Indicator	2018-11-14
PMN K953122 | JOJ Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]	Mesa Dry Heat Indicator Labels	2018-11-14
FRC Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]	Spore Strip Biological Indicator EO/Dry Heat	2016-08-29
PMN K140589 | FRC Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]	Exposure Biological Indicator	2016-08-25
PMN K930683 | FRC Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]	EZTest Indicatore Biologico Auto-Contenuto per Sterilizzazione ad ossido di etilene	2011-07-21
PMN K930683 | FRC Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]	EZTest Biological Indicator for EO Sterilization	2011-07-21
PMN K930682 | FRC Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]	Getinge Assured Biological Indicators for Steam Sterilization	2011-07-21
PMN K930682 | FRC Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]	EZTest Indicatore Biologico Auto-Contenuto	2011-07-21
PMN K930682 | FRC Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]	EZTest Biological Indicator for Steam Sterilization	2011-07-21
PMN K093794 | FRC Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]	Smart-Read EZTest Indicatore Biologico Auto-Contenuto	2011-07-21
PMN K093794 | FRC Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]	Smart-Read EZTest Biological Indicator Monitoring System	2011-07-21
PMN K062651 | JOJ Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]	ProChem EXT	2008-10-06
PMN K050591 | FRC Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]	Spore Strip Biological Indicator Dual Species	1992-06-29
PMN K032914 | FRC Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]	Spore Strip Biological Indicator Steam and Chemiclave	1992-06-29