KLO — Enzymatic Radiochemical Assay, Gentamicin Class II

FDA Device Classification

FDA product code KLO covers "Enzymatic Radiochemical Assay, Gentamicin", a Class II medical device regulated under 21 CFR 862.3450. Submissions are reviewed by the Clinical Toxicology panel.

Classification Details

Product Code
KLO
Device Class
Class II
Regulation Number
862.3450
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No