VISION POTASSIUM

K850950 · Abbott Laboratories · CEM · Aug 12, 1985 · Clinical Chemistry

Device Facts

Record IDK850950
Device NameVISION POTASSIUM
ApplicantAbbott Laboratories
Product CodeCEM · Clinical Chemistry
Decision DateAug 12, 1985
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 862.1600
Device ClassClass 2

Regulatory Classification

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.

Innolitics

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