510(k) K092407

REMEL SPECTRA MRSA by Remel, Inc. — Product Code JSO

K092407 is an FDA 510(k) premarket notification submitted by Remel, Inc. for the device "REMEL SPECTRA MRSA". The FDA issued a decision of Substantially Equivalent on October 8, 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. Remel, Inc. has at least 10 other 510(k) clearances on record.