510(k) K081013

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN by Siemens Healthcare Diagnostics — Product Code LRG

K081013 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN". The FDA issued a decision of Substantially Equivalent on September 8, 2008. 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.