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K Number
K000926
Device Name
EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER
Manufacturer
MEDICA CORP.
Date Cleared
2000-05-15

(54 days)

Product Code
CGZ,CEM,JGS
Regulation Number
862.1170
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 862.1170 Chloride test system.

(a)
Identification. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.(b)
Classification. Class II.