ARCHITECT iGentamicin
K-Number: K243500 · 2025-07-09
ApplicantAbbott Laboratories
Decision Date2025-07-09
Product CodeLCD
Advisory CommitteeTX
DecisionSubstantially Equivalent
Device Summary
ARCHITECT iGentamicin is a medical device manufactured by Abbott Laboratories. It received FDA 510(k) clearance on 2025-07-09 under approval number K243500. The device is classified under product code LCD. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ARCHITECT iGentamicin?
ARCHITECT iGentamicin is a medical device that received FDA 510(k) clearance on 2025-07-09. It is manufactured by Abbott Laboratories. The 510(k) number is K243500.
When was ARCHITECT iGentamicin approved by the FDA?
ARCHITECT iGentamicin received FDA 510(k) clearance on 2025-07-09, under approval number K243500.
What company makes ARCHITECT iGentamicin?
ARCHITECT iGentamicin is manufactured by Abbott Laboratories.
What is the FDA product code for ARCHITECT iGentamicin?
The FDA product code for ARCHITECT iGentamicin is LCD.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.