POTASSIUM AND SODIUM ELECTROLYTE ANALYZER— 510(k) K890792

Name: FDA 510(k) clearance K890792
Creator: U.S. Food and Drug Administration
Published: 1989-05-03

Substantially Equivalent

Ionetics, Inc.

FDA 510(k) clearance K890792 for POTASSIUM AND SODIUM ELECTROLYTE ANALYZER, Substantially Equivalent on 1989-05-03. Applicant: Ionetics, Inc.. Device class: 2.

Clearance details

Applicant: Ionetics, Inc.
Product code: Code CEM
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 1989-02-17
Decision date: 1989-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

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