510(k) K082340

ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS by Roche Diagnostics Corp. — Product Code CGN

K082340 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS". The FDA issued a decision of Substantially Equivalent on June 19, 2009. The device falls under product code CGN (Acid, Folic, Radioimmunoassay), a Class II device regulated under 21 CFR 862.1295. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.