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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2025-07-09 under 510(k) 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. The listed applicant is Abbott Laboratories. The 510(k) number is K243500.

When did ARCHITECT iGentamicin receive FDA 510(k) clearance?

ARCHITECT iGentamicin received FDA 510(k) clearance on 2025-07-09, under 510(k) number K243500.

Who is the listed applicant for ARCHITECT iGentamicin?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARCHITECT iGentamicin?

The FDA product code for ARCHITECT iGentamicin is LCD.

Other records listing Abbott Laboratories as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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