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.

Clearance details

Applicant
Abbott Laboratories
Product code
Code LCD
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Abbott Park, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.