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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Gentamicin
510(k) Number K243500
Device Name ARCHITECT iGentamicin
Applicant
Abbott Laboratories
100 Abbott Park Rd.
Dept. C2d8, Bldg. Ap08/A
Abbott Park,  IL  60064
Applicant Contact Weijie Jiao
Correspondent
Abbott Laboratories
100 Abbott Park Rd.
Dept. C2d8, Bldg. Ap08/A
Abbott Park,  IL  60064
Correspondent Contact Weijie Jiao
Regulation Number862.3450
Classification Product Code
LCD  
Date Received11/12/2024
Decision Date 07/09/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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