Mesa Laboratories Inc

FDA Filings

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

USA

NASDAQ

MLAB

DUNS 102530326

Mesa Laboratories Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• IBP MEDICAL GMBH

FDA Registration(s)

• Registration Number: 3003884198
• FEI Number: 3003884198
• Name: IBP MEDICAL GMBH
• Owner & Operator: MESA LABORATORIES, INC.
• Contact Address: 12100 WEST 6TH AVE. --; Lakewood CO 80228 US
• US Agent:
  • Jamie Louie
  • Mesa Laboratories, Inc.
  • 303 5654846
  • 303 9878989
  • jlouie@mesalabs.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: IKARUSALLEE 15 ; HANNOVER Niedersachsen, D30179 DE
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

• 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

• Registration Number: 1720309
• FEI Number: 1720309
• Name: MESA LABORATORIES, INC.
• Owner & Operator: MESA LABORATORIES, INC.
• Contact Address: 12100 WEST 6TH AVE. --; Lakewood CO 80228 US
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 12100 W 6th Ave ; Denver, CO 80228 US
• Establishment Type:
  • Repack or Relabel Medical Device
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID M985EXPOSSC6100 MESA LABORATORIES, INC.	ExpoSure Steam EXPO-S-SC-6-100	2023-11-30
GUDID M985EXPOSSC525 MESA LABORATORIES, INC.	ExpoSure Steam EXPO-S-SC-5-25	2023-11-30
GUDID M985EXPOSSC5100 MESA LABORATORIES, INC.	ExpoSure Steam EXPO-S-SC-5-100	2023-11-30
GUDID M9853610000 MESA LABORATORIES, INC.	Spore Strip -Steam & Chemiclave 3-6-1000	2023-07-18
GUDID M9853510000 MESA LABORATORIES, INC.	Spore Strips Steam & Chemiclave 3-5-1000	2023-07-18
GUDID M9851610001 MESA LABORATORIES, INC.	Spore Strip - EO/Dry Heat 1-6-1000	2023-07-18
GUDID M985CISSIX2 MESA LABORATORIES, INC.	ProChem SSE Emulator CI-SSIX	2021-02-19
GUDID M985CIDHI2 MESA LABORATORIES, INC.	Mesa Labs Dry Heat Indicator Labels CI-DHI	2021-02-19
GUDID M985CIBDTLF0 MESA LABORATORIES, INC.	Bowie Dick Type Test CI-BDTLF	2021-02-19
PMN K201765 Mesa Laboratories, Inc.	SmartHDM-510 System	2020-09-02
GUDID M985020583 MESA LABORATORIES, INC.	TDS Standard Solution 02.0077	2020-05-12
GUDID M985020582 MESA LABORATORIES, INC.	TDS Standard Solution 02.0076	2020-05-12
GUDID M985020081 MESA LABORATORIES, INC.	TDS Standard Solution 02.0075	2020-05-12
GUDID M985020080 MESA LABORATORIES, INC.	TDS Standard Solution 02.0074	2020-05-12
GUDID M985020079 MESA LABORATORIES, INC.	TDS Standard Solution 02.0073	2020-05-12
PMN K191496 | FKH MESA LABORATORIES, INC.	TDS Standard Solution	2020-04-16
PMN K032075 | FKH IBP MEDICAL GMBH [MESA LABORATORIES, INC.]	Secondary Reference Solution	2019-10-08
PMN K020909 | FIZ IBP MEDICAL GMBH [MESA LABORATORIES, INC.]	HDM99	2019-10-08
PMN K020908 | FIZ IBP MEDICAL GMBH [MESA LABORATORIES, INC.]	HDM97	2019-10-08
GUDID M985CIEXT1 MESA LABORATORIES, INC.	ProChem EXT CI-EXT	2019-10-07
PMN K191496 Mesa Laboratories, Inc.	TDS Standard Solution	2019-08-05
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 K122362 | FRC MESA LABORATORIES, INC.	Smart-Well Model 1710 EZTest Incubator	2016-07-27
PMN K150657 Mesa Laboratories, Inc.	Phoenix XL Dialysate Meter	2015-09-21
PMN K140589 MESA LABORATORIES, INC.	STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR	2014-12-03
PMN K130100 MESA LABORATORIES, INC.	COMINED STANDARD SOLUTION	2013-04-18
PMN K122362 MESA LABORATORIES, INC.	SMART-WELL INCUBATOR	2013-03-26
PMN K112018 MESA LABORATORIES, INC.	SMART READ EZTEST STEAM	2012-01-30
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 K091950 | FRC MESA LABORATORIES, INC.	SMART-WELL EZTEST INCUBATOR	2011-07-21
PMN K974127 | FIP MESA LABORATORIES, INC.	HYDRA METER	2010-05-17
PMN K955298 | FIZ MESA LABORATORIES, INC.	PHOENIX DIALYSATE METER	2010-05-17
PMN K920810 | FIZ MESA LABORATORIES, INC.	NEO-STAT DIALYSATE METER	2010-05-17
PMN K050812 | FIZ MESA LABORATORIES, INC.	90XL INSTRUMENTATION SYSTEM	2010-05-17
PMN K033330 | FKH MESA LABORATORIES, INC.	Conductivity Standard Solution	2010-05-14
PMN K062651 | JOJ Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]	ProChem EXT	2008-10-06
PMN K050812 MESA LABORATORIES, INC.	90XL INSTRUMENTATION SYSTEM	2005-05-05
PMN K033330 MESA LABORATORIES, INC.	CONDUCTIVITY/TDS CALIBRATOR SOLUTION	2004-02-27
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
JCC MESA LABORATORIES, INC.	PH BUFFER SOLUTIONS	1992-06-18
BYX MESA LABORATORIES, INC.	MONITORING LINE	1992-06-18

Related Finance Registrations

NCAGE Code	00V11	MESA LABORATORIES, INC.
CAGE Code	00V11	MESA LABORATORIES, INC.
CAGE Code	0X5K4	MESA LABORATORIES INC. MESA LABORATORIES
CAGE Code	6VYQ0	MESA LABORATORIES INC. MESA LABORATORIES
CAGE Code	71WR0	MESA LABORATORIES INC OMAHA DIVISION
S.A.M. Registration	0X5K4 [102530326]	MESA LABORATORIES INC.
S.A.M. Registration	00V11 [78727030]	MESA LABORATORIES, INC.
DUNS	018528578	MESA LABORATORIES INC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019121333117	Tokyo ,Japan -> Los Angeles, California	TORQUEANALYZER S/N MS963 STAINLESS STEEL HS CODE:8460.12	1 CAS
2019120949942	Tokyo ,Japan -> Los Angeles, California	TORQUEANALYZER S/N MS963 STAINLESS STEEL HS CODE:8460.12	1 CAS
2019120647303	Tokyo ,Japan -> Los Angeles, California	TORQUEANALYZER S/N MS963 STAINLESS STEEL HS CODE:8460.12	1 CAS
2019120450979	Tokyo ,Japan -> Los Angeles, California	TORQUEANALYZER S/N MS963 STAINLESS STEEL HS CODE:8460.12	1 CAS
2019120256847	Tokyo ,Japan -> Los Angeles, California	TORQUEANALYZER S/N MS963 STAINLESS STEEL HS CODE:8460.12	1 CAS
2019113099651	Tokyo ,Japan -> Los Angeles, California	TORQUEANALYZER S/N MS963 STAINLESS STEEL HS CODE:8460.12	1 CAS
2019112844821	Tokyo ,Japan -> Los Angeles, California	TORQUEANALYZER S/N MS963 STAINLESS STEEL HS CODE:8460.12	1 CAS