FDA Product Code JTN: Susceptibility Test Discs, Antimicrobial
Under FDA product code JTN, antimicrobial susceptibility test discs are cleared for disk diffusion testing in clinical microbiology laboratories.
These paper discs are impregnated with a specific concentration of an antibiotic and placed on an agar plate inoculated with the test organism. The diameter of the inhibition zone around each disc indicates whether the organism is susceptible, intermediate, or resistant to that antibiotic.
JTN devices are Class II medical devices, regulated under 21 CFR 866.1620 and reviewed by the FDA Microbiology panel.
Leading manufacturers include Hardy Diagnostics and Becton, Dickinson and Company.
List of Susceptibility Test Discs, Antimicrobial devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Susceptibility Test Discs, Antimicrobial devices (product code JTN). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →