510(k) K983306

SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN by Accumed Intl., Inc. — Product Code LTT

K983306 is an FDA 510(k) premarket notification submitted by Accumed Intl., Inc. for the device "SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN". The FDA issued a decision of Substantially Equivalent on Dec 18, 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 11 other 510(k) clearances on record.