510(k) K101425

MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES by Siemens Healthcare Diagnostics — Product Code LRG

K101425 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES". The FDA issued a decision of Substantially Equivalent on September 10, 2010. The device falls under product code LRG (Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems), a Class II device regulated under 21 CFR 866.1640. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.