Cleared Traditional

Cholesterol2

K203597 · Abbott Ireland Diagnostics Division · Chemistry
Jun 2022
Decision
568d
Days
Class 1
Risk

About This 510(k) Submission

K203597 is an FDA 510(k) clearance for the Cholesterol2, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Abbott Ireland Diagnostics Division (Longford, IE). The FDA issued a Cleared decision on June 30, 2022, 568 days after receiving the submission on December 9, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K203597 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 2020
Decision Date June 30, 2022
Days to Decision 568 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CHH — Enzymatic Esterase--oxidase, Cholesterol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1175

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