510(k) K983309

SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN by Accumed Intl., Inc. — Product Code LTT

K983309 is an FDA 510(k) premarket notification submitted by Accumed Intl., Inc. for the device "SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN". The FDA issued a decision of Substantially Equivalent on December 14, 1998. The device falls under product code LTT (Panels, Test, Susceptibility, Antimicrobial), a Class II device regulated under 21 CFR 866.1640. Accumed Intl., Inc. has at least 10 other 510(k) clearances on record.