FDA 510(k) Application Details - K243500

Device Classification Name	Enzyme Immunoassay, Gentamicin   More FDA Info for this Device
510(K) Number	K243500
Device Name	Enzyme Immunoassay, Gentamicin
Applicant	Abbott Laboratories 100 Abbott Park Road Dept. C2D8, Building AP08/A Abbott Park, IL 60064 US Other 510(k) Applications for this Company
Contact	Weijie Jiao Other 510(k) Applications for this Contact
Regulation Number	862.3450   More FDA Info for this Regulation Number
Classification Product Code	LCD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2024
Decision Date	07/09/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review