510(k) K150039

MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL) by Siemens Healthcare Diagnostics, Inc. — Product Code LTT

K150039 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)". The FDA issued a decision of Substantially Equivalent on July 2, 2015. The device falls under product code LTT (Panels, Test, Susceptibility, Antimicrobial), a Class II device regulated under 21 CFR 866.1640. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.