Medical Device Manufacturer · US , Lakewood , CO

Mesa Laboratories, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2004

Recent clearances: SmartHDM-510 System, TDS Standard Solution

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Mesa Laboratories, Inc. Gastroenterology & Urology ✕

6 devices

1-6 of 6

Cleared Sep 02, 2020

SmartHDM-510 System

Gastroenterology & Urology · 65d

Cleared Aug 05, 2019

TDS Standard Solution

Gastroenterology & Urology · 61d

Cleared Sep 21, 2015

Phoenix XL Dialysate Meter

Gastroenterology & Urology · 192d

Cleared Apr 18, 2013

COMINED STANDARD SOLUTION

Gastroenterology & Urology · 93d

Cleared May 05, 2005

90XL INSTRUMENTATION SYSTEM

Gastroenterology & Urology · 35d

Cleared Feb 27, 2004

CONDUCTIVITY/TDS CALIBRATOR SOLUTION

Gastroenterology & Urology · 134d

Data Source

Sourced from the FDA 510(k) public files . 175,218 total devices indexed.

Last updated: May 28, 2026