MESA LABORATORIES, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1720309	1720309	MESA LABORATORIES, INC.	1	Y	2026-01-01	12100 W 6th Ave Denver CO US 80228

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
32901	1848817850	K974127	HYDRA METER	FIP	1997-12-19
32901	1118202680	K955298	PHOENIX DIALYSATE METER	FIZ	1996-02-29
32901	1639668144	K920810	NEO-STAT DIALYSATE METER	FIZ	1993-01-15
32901	1433941066	K191496	TDS Standard Solution	FKH	2019-08-05
32901	1941696493	K150657	Phoenix XL Dialysate Meter	FIZ	2015-09-21
32901	1023186307	K130100	COMINED STANDARD SOLUTION	FKH	2013-04-18
32901	1714438168	K122362	SMART-WELL INCUBATOR	FRC	2013-03-26
32901	1991779459	K091950	SMART-WELL EZTEST INCUBATOR	FRC	2010-01-15
32901	1515632063	K050812	90XL INSTRUMENTATION SYSTEM	FIZ	2005-05-05
32901	1031687538	K033330	CONDUCTIVITY/TDS CALIBRATOR SOLUTION	FKH	2004-02-27
32901	1564190632	K020908	HDM97	FIZ	2002-05-22
32901	1205805833
32901	1875968438

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
FIZ	5	2015-09-21
FKH	3	2019-08-05
FRC	2	2013-03-26
FIP	1	1997-12-19

PMN#

SmartHDM-510 System
2020-09-02
Mesa Laboratories, Inc.
TDS Standard Solution
2019-08-05
Mesa Laboratories, Inc.
Phoenix XL Dialysate Meter
2015-09-21
Mesa Laboratories, Inc.
STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR
2014-12-03
MESA LABORATORIES, INC.
COMINED STANDARD SOLUTION
2013-04-18
MESA LABORATORIES, INC.
SMART-WELL INCUBATOR
2013-03-26
MESA LABORATORIES, INC.
SMART READ EZTEST STEAM
2012-01-30
MESA LABORATORIES, INC.
90XL INSTRUMENTATION SYSTEM
2005-05-05
MESA LABORATORIES, INC.
CONDUCTIVITY/TDS CALIBRATOR SOLUTION
2004-02-27
MESA LABORATORIES, INC.

GUDID#

Dual Spore Strips - Test - Mesa Labs dual species spore strip tests- 10e5/10e6 population
MESA LABORATORIES, INC.
2017-10-20
Mesa Labs Dry Heat Indicator Labels - Dry Heat Indicator Labels - 1000 labels per roll, 10 rolls per pack
MESA LABORATORIES, INC.
2016-11-30
ProChem SSE Emulator - Mesa Labs ProChem SSE Emulator
MESA LABORATORIES, INC.
2016-11-30
Bowie Dick Type Test - ProChem B-D Bowie Dick Type Test pack
MESA LABORATORIES, INC.
2016-10-24
Spore Strip - Mesa Labs atrophaeus spore strips for Ethylene oxide/Dry Heat, 10e4 population. 100 count package.
MESA LABORATORIES, INC.
2025-01-15
Spore Strip - EO/Dry Heat - Mesa Labs atrophaeus spore strip for ethylene oxide/dry heat. 10e6. 100 count package.
MESA LABORATORIES, INC.
2025-01-15
Spore Strip - Mesa Labs steam spore strip. 10e4 population. 100 count package.
MESA LABORATORIES, INC.
2025-01-15
Spore Strip Steam & Chemiclave - Mesa Labs steam spore strip 10e5 population. 100 count package
MESA LABORATORIES, INC.
2025-01-15
Spore Strip Steam & Chemiclave - Mesa Labs steam spore strips-10e6 population 100 count package
MESA LABORATORIES, INC.
2025-01-15
Dual Spore Strips - Control - Mesa Labs dual species spore strip controls. 10e5/10e6 population. 1000 count package.
MESA LABORATORIES, INC.
2025-01-15
Dual Spore Strips - Test - Mesa Labs dual species spore strips. 10e5/10e6 population. 1000 count package.
MESA LABORATORIES, INC.
2025-01-15
Dual Spore Strip - Test - Dual species spore strip for use in steam, ethylene oxide, dry heat, or Chemiclave sterilizers. 10e5/10e6 population. 100 count bags.
MESA LABORATORIES, INC.
2025-01-15
Spore Strip - Mesa Labs atrophaeus spore strips for Ethylene oxide/Dry Heat, 10e4 population. 100 count package.
MESA LABORATORIES, INC.
2025-01-15
Spore Strip - EO/Dry Heat - Mesa Labs atrophaeus spore strip for ethylene oxide/dry heat. 10e6. 100 count package.
MESA LABORATORIES, INC.
2025-01-15
Spore Strip - Mesa Labs steam spore strip. 10e4 population. 100 count package.
MESA LABORATORIES, INC.
2025-01-15
Spore Strip Steam & Chemiclave - Mesa Labs steam spore strip 10e5 population. 100 count package
MESA LABORATORIES, INC.
2025-01-15
Spore Strip Steam & Chemiclave - Mesa Labs steam spore strips-10e6 population 100 count package
MESA LABORATORIES, INC.
2025-01-15
Dual Spore Strips - Control - Mesa Labs dual species spore strip controls. 10e5/10e6 population. 1000 count package.
MESA LABORATORIES, INC.
2025-01-15
Dual Spore Strips - Test - Mesa Labs dual species spore strips. 10e5/10e6 population. 1000 count package.
MESA LABORATORIES, INC.
2025-01-15
1017950 HealthFirst Mail-In Spore Testing Service, 52 Tests - Private label MIST product
MESA LABORATORIES, INC.
2024-12-18
1017960 HealthFirst Mail-In Spore Testing Service, 12 Test - Private label MIST product
MESA LABORATORIES, INC.
2024-12-18
ExpoSure Steam - Self contained biological indicator, 10e5 population, 100 count box
MESA LABORATORIES, INC.
2023-11-22
ExpoSure Steam - Self contained biological indicator, 10e5 population, 25 count box
MESA LABORATORIES, INC.
2023-11-22
ExpoSure Steam - Self contained biological indicator, 10e6 population, 100 count in box
MESA LABORATORIES, INC.
2023-11-22
ExpoSure Steam - Self contained biological indicator, 10e6 population, 25 count box
MESA LABORATORIES, INC.
2023-11-22
ExpoSure Steam - Self contained biological indicator, 10e5 population, 100 count box
MESA LABORATORIES, INC.
2023-11-22
ExpoSure Steam - Self contained biological indicator, 10e5 population, 25 count box
MESA LABORATORIES, INC.
2023-11-22
ExpoSure Steam - Self contained biological indicator, 10e6 population, 100 count in box
MESA LABORATORIES, INC.
2023-11-22
Spore Strips Steam & Chemiclave - Geobacillus Stearothermophilus log 5 strip in 1000ct bag private label for GKE
MESA LABORATORIES, INC.
2023-07-10
Spore Strip -Steam & Chemiclave - Geobacillus strearothermophilus log 6 strip in 1000ct bag private label for GKE
MESA LABORATORIES, INC.
2023-07-10
Spore Strip - EO/Dry Heat - Bacillus atrophaeus log 6 strips in 1000ct bag private label for GKE
MESA LABORATORIES, INC.
2023-07-10
Spore Strips Steam & Chemiclave - Geobacillus Stearothermophilus log 5 strip in 1000ct bag private label for GKE
MESA LABORATORIES, INC.
2023-07-10
Spore Strip -Steam & Chemiclave - Geobacillus strearothermophilus log 6 strip in 1000ct bag private label for GKE
MESA LABORATORIES, INC.
2023-07-10
Mesa Labs Dry Heat Indicator Labels - Dry Heat Indicator Labels - 1000 labels per roll, 10 rolls per pack
MESA LABORATORIES, INC.
2016-11-30
ProChem SSE Emulator - Mesa Labs ProChem SSE Emulator
MESA LABORATORIES, INC.
2016-11-30
MesaLabs - new version of Mesa Labs pHoenix XL Dialysate Meter
MESA LABORATORIES, INC.
2020-09-14
TDS Standard Solution - Total Dissolved Solids Solution 15ppm 23.8uS/cm 1Qt
MESA LABORATORIES, INC.
2020-05-04
TDS Standard Solution - Total Dissolved Solids Solution 150ppm 229uS/cm 1Qt
MESA LABORATORIES, INC.
2020-05-04
TDS Standard Solution - Total Dissolved Solids Solution 1500ppm 2060uS/cm 1Qt
MESA LABORATORIES, INC.
2020-05-04
TDS Standard Solution - Total Dissolved Solids Solution 15ppm 23.8uS/cm 1Pt
MESA LABORATORIES, INC.
2020-05-04

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