510(k) K081212

MRSASELECT - EXTENDED INCUBATION by Bio-Rad — Product Code JSO

K081212 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "MRSASELECT - EXTENDED INCUBATION". The FDA issued a decision of Substantially Equivalent on June 13, 2008. 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. Bio-Rad has at least 10 other 510(k) clearances on record.