510(k) K093631

B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644 by Siemens Healthcare Diagnostics — Product Code CDD

K093631 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644". The FDA issued a decision of Substantially Equivalent on February 12, 2010. The device falls under product code CDD (Radioassay, Vitamin B12), a Class II device regulated under 21 CFR 862.1810. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.