Cleared Traditional

Urea Nitrogen2

K203771 · Abbott Ireland Diagnostics Division · Chemistry
May 2022
Decision
524d
Days
Class 2
Risk

About This 510(k) Submission

K203771 is an FDA 510(k) clearance for the Urea Nitrogen2, a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II — Special Controls, product code CDQ), submitted by Abbott Ireland Diagnostics Division (Longford, IE). The FDA issued a Cleared decision on May 31, 2022, 524 days after receiving the submission on December 23, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K203771 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2020
Decision Date May 31, 2022
Days to Decision 524 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDQ — Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770

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