510(k) K103716

ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET by Roche Diagnostics — Product Code CGN

K103716 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET". The FDA issued a decision of Substantially Equivalent on May 12, 2011. The device falls under product code CGN (Acid, Folic, Radioimmunoassay), a Class II device regulated under 21 CFR 862.1295. Roche Diagnostics has at least 10 other 510(k) clearances on record.