Urea Nitrogen2— 510(k) K203771

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.

Clearance details

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

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