510(k) K102922

HARDYCHROM MRSA by Hardy Diagnostics — Product Code JSO

K102922 is an FDA 510(k) premarket notification submitted by Hardy Diagnostics for the device "HARDYCHROM MRSA". The FDA issued a decision of Substantially Equivalent on May 4, 2011. The device falls under product code JSO (Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar), a Class II device regulated under 21 CFR 866.1700. Hardy Diagnostics has at least 10 other 510(k) clearances on record.