Mesa Laboratories, Inc.
Mesa Laboratories, Inc. holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2020, with 3 FDA device recalls on record.
Top product codes for Mesa Laboratories, Inc.
FDA recalls by Mesa Laboratories, Inc.
- Z-2159-2017 — MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Product No. : 02.0027, 020510 (carton of 6 of 02.0027). Polyethylene bottle Conductivity/TDS Calibrator solutions are a secondary standard solution used for the calibration of conductivity/TDS cells together with conductivity/TDS measurement instruments. The conductivity/TDS cells and instruments may be indicated for calibrating the conductivity measurement function of hemodialysis machines and water purification equipment for hemodialysis, or for verifying proper function of hemodialysis machine or water purification equipment measurement functions. These solutions are used remotely from the hemodialysis machine or water purification equipment, and do not come into contact with the patient.
- Z-1104-2017 — ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care provider to accompany products being sterilized through steam sterilization procedure and to monitor adequacy of sterilization.
- Z-0175-2014 — pH 7.0 Buffer Solution Pint and Quart Bottles, Part Number 02.0030 for Pints and 02.0031 for Quarts. Packaged in Plastic Bottles. Can be sold individually or in cartons with 6 bottles per box (for quart bottles only). Used in the hemodialysis setting to calibrate pH meters.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Mesa Laboratories, Inc.
- K201765 — SmartHDM-510 System
- K191496 — TDS Standard Solution
- K150657 — Phoenix XL Dialysate Meter
- K140589 — STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR
- K130100 — COMINED STANDARD SOLUTION
- K122362 — SMART-WELL INCUBATOR
- K112018 — SMART READ EZTEST STEAM
- K050812 — 90XL INSTRUMENTATION SYSTEM
- K033330 — CONDUCTIVITY/TDS CALIBRATOR SOLUTION
Data sourced from openFDA. This site is unofficial and independent of the FDA.