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510(k) Data Aggregation
K Number
K121823Device Name
CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC
Manufacturer
WESCOR, INC.
Date Cleared
2013-03-27
(279 days)
Product Code
JFS, JJX
Regulation Number
862.1170Why did this record match?
Product Code :
JFS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wescor ChloroChek Chloridometer test system is intended for the quantitative in vitro diagnostic determination of chloride in human sweat using the principle of coulometric titration. Sweat chloride measurements are used in the diagnosis of Cystic Fibrosis. It is for use in Clinical Laboratory settings. The Wescor ChloroChek Chloridometer test system consists of the ChloroChek Chloridometer and the ChloroChek Reagent Set.
The ChloroChek Reagent Set (SS-248) is to be used on the ChloroChek. It is used as the titration matrix during the titration process.
The 100 mmol/L NaCl/H2O Standard Solution (SS-251), is to be used on the ChloroChek. It is used as a calibration verifier, and quality control solution.
The Wescor Sweat Controls (SS-150), levels #1, #2, and #3, are to be used on the ChloroChek. They are used as quality control solutions.
Device Description
The CHLOROCHEK™ Chloridometer® test system includes the ChloroChek Chloridometer analyzer and the ChloroChek Reagent Set. The system is for in-vitro diagnostics intended to measure the level of chloride in human sweat. It is a bench top chloride titrator for laboratory determinations of chloride concentrations.
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