510(k) K131275

MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS by Siemens Helathcare Diagnostics, Inc. — Product Code LTT

K131275 is an FDA 510(k) premarket notification submitted by Siemens Helathcare Diagnostics, Inc. for the device "MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS". The FDA issued a decision of Substantially Equivalent on November 8, 2013. The device falls under product code LTT (Panels, Test, Susceptibility, Antimicrobial), a Class II device regulated under 21 CFR 866.1640. Siemens Helathcare Diagnostics, Inc. has at least 1 other 510(k) clearance on record.