KZX — Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Tobramycin Class II

FDA Device Classification

FDA product code KZX covers "Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Tobramycin", a Class II medical device regulated under 21 CFR 862.3900. Submissions are reviewed by the Clinical Toxicology panel.

Classification Details

Product Code
KZX
Device Class
Class II
Regulation Number
862.3900
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No