510(k) K071466

DCA VANTAGE, MODEL 5075 by Siemens Medical Solutions Diagnostics — Product Code LCP

K071466 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions Diagnostics for the device "DCA VANTAGE, MODEL 5075". The FDA issued a decision of Substantially Equivalent on October 9, 2007. 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.