EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+)

• K Number: K961115
• Device Name: EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+)
• Manufacturer: JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
• Date Cleared: 1996-05-07 ( 48 days)
• Product Code: CEM , JIX , JJY
• Regulation Number: 862.1600
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A
• Predicate For: K073157

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 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.