SODIUM & POTASSIUM TEST KIT— 510(k) K810253

Name: FDA 510(k) clearance K810253
Creator: U.S. Food and Drug Administration
Published: 1981-02-10

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K810253 for SODIUM & POTASSIUM TEST KIT, Substantially Equivalent on 1981-02-10. Applicant: Mallinckrodt Critical Care. Device class: 2.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code JGM
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 1981-01-30
Decision date: 1981-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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