510(k) K021184

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

K021184 is an FDA 510(k) premarket notification submitted by Dade Microscan, Inc. for the device "MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN". The FDA issued a decision of Substantially Equivalent on June 20, 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.