510(k) K060929

IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6 by Diagnostic Products Corporation — Product Code CDD

K060929 is an FDA 510(k) premarket notification submitted by Diagnostic Products Corporation for the device "IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6". The FDA issued a decision of Substantially Equivalent on April 28, 2006. The device falls under product code CDD (Radioassay, Vitamin B12), a Class II device regulated under 21 CFR 862.1810. Diagnostic Products Corporation has at least 2 other 510(k) clearances on record.