Cleared Traditional

Total Bilirubin2

K223324 · Abbott Ireland Diagnostics Division · Chemistry
Dec 2022
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K223324 is an FDA 510(k) clearance for the Total Bilirubin2, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Abbott Ireland Diagnostics Division (Longsford, IE). The FDA issued a Cleared decision on December 29, 2022, 59 days after receiving the submission on October 31, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K223324 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2022
Decision Date December 29, 2022
Days to Decision 59 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CIG — Diazo Colorimetry, Bilirubin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1110

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