Urea Nitrogen2— 510(k) K203771

Name: FDA 510(k) clearance K203771
Creator: U.S. Food and Drug Administration
Published: 2022-05-31

Substantially Equivalent

Abbott Ireland Diagnostics Division

FDA 510(k) clearance K203771 for Urea Nitrogen2, Substantially Equivalent on 2022-05-31. Applicant: Abbott Ireland Diagnostics Division. Device class: 2.

Clearance details

Applicant: Abbott Ireland Diagnostics Division
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 2020-12-23
Decision date: 2022-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longford, IE

Download summary PDF View on FDA.gov ↗

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