510(k) K043589

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM by Dade Microscan, Inc. — Product Code JWY

K043589 is an FDA 510(k) premarket notification submitted by Dade Microscan, Inc. for the device "MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM". The FDA issued a decision of Substantially Equivalent on February 14, 2005. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), a Class II device regulated under 21 CFR 866.1640. Dade Microscan, Inc. has at least 10 other 510(k) clearances on record.