510(k) K100589

MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS by Bio-Rad — Product Code JSO

K100589 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS". The FDA issued a decision of Substantially Equivalent on October 29, 2010. 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.