510(k) K091264

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017 by Siemens Healthcare Diagnostics — Product Code LTT

K091264 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017". The FDA issued a decision of Substantially Equivalent on July 22, 2009. The device falls under product code LTT (Panels, Test, Susceptibility, Antimicrobial), a Class II device regulated under 21 CFR 866.1640. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.