510(k) K081895

ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS by Siemens Medical Solutions Diagnostics — Product Code LCP

K081895 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions Diagnostics for the device "ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS". The FDA issued a decision of Substantially Equivalent on January 8, 2009. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Siemens Medical Solutions Diagnostics has at least 10 other 510(k) clearances on record.