CONDUCTIVITY/TDS CALIBRATOR SOLUTION— 510(k) K033330

Clearance details

Applicant

Mesa Laboratories, Inc.

Product code

Code FKH

Device class

Class 2

Regulation

21 CFR 876.5820

Advisory panel

Gastroenterology, Urology

Date received

2003-10-16

Decision date

2004-02-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Lakewood, CO, US

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• 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.Class II·Terminated·Mesa Laboratories, Inc.·20170512

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K033330.