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K Number
K961326

Validate with FDA (Live)

Device Name
EASY STAT SODIUM/POTASSIUM/LITHIUM ANALYZER
Manufacturer
MEDICA CORP.
Date Cleared
1996-06-21

(74 days)

Product Code
CEM,JGS,JIH
Regulation Number
862.1600
Type
Traditional
Panel
Clinical Chemistry
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 862.1600 Potassium test system.

(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.