510(k) K021078

MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN by Dade Microscan, Inc. — Product Code LTT

K021078 is an FDA 510(k) premarket notification submitted by Dade Microscan, Inc. for the device "MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN". The FDA issued a decision of Substantially Equivalent on June 6, 2002. The device falls under product code LTT (Panels, Test, Susceptibility, Antimicrobial), a Class II device regulated under 21 CFR 866.1640. Dade Microscan, Inc. has at least 10 other 510(k) clearances on record.