ARCHITECT iGentamicin— 510(k) K243500

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K243500 for ARCHITECT iGentamicin, Substantially Equivalent on 2025-07-09. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LCD
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 2024-11-12
Decision date: 2025-07-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCD

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K042479 — VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 142005-01-06
K020704 — ROCHE ONLINE GENTAMICIN2002-07-12
K012978 — RANDOX GENTAMICIN2001-09-18

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Data sourced from openFDA. This site is unofficial and independent of the FDA.