510(k) K083262

MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML) by Siemens Healthcare Diagnostics — Product Code LTT

K083262 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML)". The FDA issued a decision of Substantially Equivalent on February 18, 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.