Cleared Traditional

Creatinine2

K210452 · Abbott Ireland Diagnostics Division · Chemistry
Mar 2022
Decision
399d
Days
Class 2
Risk

About This 510(k) Submission

K210452 is an FDA 510(k) clearance for the Creatinine2, a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by Abbott Ireland Diagnostics Division (Longford, IE). The FDA issued a Cleared decision on March 22, 2022, 399 days after receiving the submission on February 16, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K210452 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 2021
Decision Date March 22, 2022
Days to Decision 399 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGX — Alkaline Picrate, Colorimetry, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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