Cleared Special

ARCHITECT iGentamicin

K243500 · Abbott Laboratories · Toxicology
Jul 2025
Decision
239d
Days
Class 2
Risk

About This 510(k) Submission

K243500 is an FDA 510(k) clearance for the ARCHITECT iGentamicin, a Enzyme Immunoassay, Gentamicin (Class II — Special Controls, product code LCD), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 9, 2025, 239 days after receiving the submission on November 12, 2024. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number K243500 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2024
Decision Date July 09, 2025
Days to Decision 239 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LCD — Enzyme Immunoassay, Gentamicin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3450

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