510(k) K020506

MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE (0.5-128 UG/ML) by Dade Microscan, Inc. — Product Code LON

K020506 is an FDA 510(k) premarket notification submitted by Dade Microscan, Inc. for the device "MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE (0.5-128 UG/ML)". The FDA issued a decision of Substantially Equivalent on April 17, 2002. The device falls under product code LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation), a Class II device regulated under 21 CFR 866.1645. Dade Microscan, Inc. has at least 10 other 510(k) clearances on record.