510(k) K233534

Viral Transport Medium by Hardy Diagnostics — Product Code JSM

K233534 is an FDA 510(k) premarket notification submitted by Hardy Diagnostics for the device "Viral Transport Medium". The FDA issued a decision of Substantially Equivalent on August 2, 2024. The device falls under product code JSM (Culture Media, Non-Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Hardy Diagnostics has at least 10 other 510(k) clearances on record.