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.

USANASDAQMLABDUNS 102530326

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

FDA Registration(s)
Registration Number3003884198
FEI Number3003884198
NameIBP MEDICAL GMBH
Owner & OperatorMESA LABORATORIES, INC.
Contact Address12100 WEST 6TH AVE. --
Lakewood CO 80228 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressIKARUSALLEE 15
HANNOVER Niedersachsen, D30179 DE
Establishment TypeComplaint File Establishment per 21 CFR 820.198



Registration Number3013667284
FEI Number3013667284
NameMesa Laboratories Bozeman Manufacturing Facility (Zoot)
Owner & OperatorMESA LABORATORIES, INC.
Contact Address12100 WEST 6TH AVE. --
Lakewood CO 80228 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address625 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 Number1720309
FEI Number1720309
NameMESA LABORATORIES, INC.
Owner & OperatorMESA LABORATORIES, INC.
Contact Address12100 WEST 6TH AVE. --
Lakewood CO 80228 US
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address12100 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
DeviceDate
Mesa Laboratories, Inc.
SmartHDM-510 System2020-09-02
MESA LABORATORIES, INC.
TDS Standard Solution 02.00772020-05-12
MESA LABORATORIES, INC.
TDS Standard Solution 02.00762020-05-12
MESA LABORATORIES, INC.
TDS Standard Solution 02.00752020-05-12
MESA LABORATORIES, INC.
TDS Standard Solution 02.00742020-05-12
MESA LABORATORIES, INC.
TDS Standard Solution 02.00732020-05-12
MESA LABORATORIES, INC.
TDS Standard Solution2020-04-16
IBP MEDICAL GMBH [MESA LABORATORIES, INC.]
Secondary Reference Solution2019-10-08
IBP MEDICAL GMBH [MESA LABORATORIES, INC.]
HDM992019-10-08
IBP MEDICAL GMBH [MESA LABORATORIES, INC.]
HDM972019-10-08
MESA LABORATORIES, INC.
ProChem EXT CI-EXT2019-10-07
Mesa Laboratories, Inc.
TDS Standard Solution2019-08-05
Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]
Smart-Read EZTest Steam Biological Test Pack with Instant Readout Integrator2018-12-04
Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]
EZTest Biological Test Pack for Use in Steam Sterilizers2018-12-04
Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]
Mesa ProChem B-D Test Pack2018-11-14
Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]
Mesa ProChem B-D 121 Bowie-Dick Test Pack2018-11-14
Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]
ProSpore Biological Indicator2018-11-14
Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]
Mesa Dry Heat Indicator Labels2018-11-14
Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]
Spore Strip Biological Indicator EO/Dry Heat2016-08-29
Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]
Exposure Biological Indicator2016-08-25
MESA LABORATORIES, INC.
Smart-Well Model 1710 EZTest Incubator2016-07-27
Mesa Laboratories, Inc.
Phoenix XL Dialysate Meter2015-09-21
MESA LABORATORIES, INC.
STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR2014-12-03
MESA LABORATORIES, INC.
COMINED STANDARD SOLUTION2013-04-18
MESA LABORATORIES, INC.
SMART-WELL INCUBATOR2013-03-26
MESA LABORATORIES, INC.
SMART READ EZTEST STEAM2012-01-30
Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]
EZTest Indicatore Biologico Auto-Contenuto per Sterilizzazione ad ossido di etilene2011-07-21
Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]
EZTest Biological Indicator for EO Sterilization2011-07-21
Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]
Getinge Assured Biological Indicators for Steam Sterilization2011-07-21
Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]
EZTest Indicatore Biologico Auto-Contenuto2011-07-21
Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]
EZTest Biological Indicator for Steam Sterilization2011-07-21
Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]
Smart-Read EZTest Indicatore Biologico Auto-Contenuto2011-07-21
Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]
Smart-Read EZTest Biological Indicator Monitoring System2011-07-21
MESA LABORATORIES, INC.
SMART-WELL EZTEST INCUBATOR2011-07-21
MESA LABORATORIES, INC.
HYDRA METER2010-05-17
MESA LABORATORIES, INC.
PHOENIX DIALYSATE METER2010-05-17
MESA LABORATORIES, INC.
NEO-STAT DIALYSATE METER2010-05-17
MESA LABORATORIES, INC.
90XL INSTRUMENTATION SYSTEM2010-05-17
MESA LABORATORIES, INC.
Conductivity Standard Solution2010-05-14
Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]
ProChem EXT2008-10-06
MESA LABORATORIES, INC.
90XL INSTRUMENTATION SYSTEM2005-05-05
MESA LABORATORIES, INC.
CONDUCTIVITY/TDS CALIBRATOR SOLUTION2004-02-27
Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]
Spore Strip Biological Indicator Dual Species1992-06-29
Mesa Laboratories Bozeman Manufacturing Facility (Zoot) [MESA LABORATORIES, INC.]
Spore Strip Biological Indicator Steam and Chemiclave1992-06-29
MESA LABORATORIES, INC.
PH BUFFER SOLUTIONS1992-06-18
MESA LABORATORIES, INC.
MONITORING LINE1992-06-18

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