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
3013667284	3013667284	Mesa Laboratories Bozeman Manufacturing Facility (Zoot)	1	N	2026-01-01	625 Zoot Way Bozeman MT US 59718

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
208238	1449473640	K990246	STERI-PAK LF BOWIE-DICK TEST PACK	JOJ	1999-06-10
32901	1848817850	K974127	HYDRA METER	FIP	1997-12-19
208238	1039734934	K971432	PROSPORE	FRC	1997-05-20
32901	1118202680	K955298	PHOENIX DIALYSATE METER	FIZ	1996-02-29
208238	1552283212	K953122	STERITEC DRY HEAT INDICATOR LABEL	JOJ	1997-04-02
208238	1065707851	K930683	EZTEST-GAS	FRC	1997-03-04
208238	2010759733	K930682	EZTEST-STEAM	FRC	1994-04-04
32901	1639668144	K920810	NEO-STAT DIALYSATE METER	FIZ	1993-01-15
32901	1433941066	K191496	TDS Standard Solution	FKH	2019-08-05
208238	1595421714	K152630	VERIFY STEAM Integrating Indicator	JOJ	2016-05-12
32901	1941696493	K150657	Phoenix XL Dialysate Meter	FIZ	2015-09-21
208238	1523142613	K140589	STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR	FRC	2014-12-03
32901	1023186307	K130100	COMINED STANDARD SOLUTION	FKH	2013-04-18
32901	1714438168	K122362	SMART-WELL INCUBATOR	FRC	2013-03-26
208238	1314703088	K103000	SMART READ BIOLOGICAL TEST PACK	JOJ	2011-02-11
208238	1924763117	K093794	SMART-READ EZTEST-STEAM SCBI AND TEST PACK	FRC	2010-05-14
32901	1991779459	K091950	SMART-WELL EZTEST INCUBATOR	FRC	2010-01-15
208238	1801078806	K062651	PROCHEM EXT CHEMICAL INTEGRATOR	JOJ	2007-03-15
32901	1515632063	K050812	90XL INSTRUMENTATION SYSTEM	FIZ	2005-05-05
208238	1057492605	K050591	MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS	FRC	2005-03-23
32901	1031687538	K033330	CONDUCTIVITY/TDS CALIBRATOR SOLUTION	FKH	2004-02-27
208238	1205855913	K032914	MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS	FRC	2004-05-25
32901	1564190632	K020908	HDM97	FIZ	2002-05-22
208238	1184169866	K001444	STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103	JOJ	2000-05-15
32901	1205805833
208238	1299749994
32901	1875968438

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
FRC	9	2014-12-03
JOJ	6	2016-05-12
FIZ	5	2015-09-21
FKH	3	2019-08-05
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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