510(k) K031756

ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY by Roche Diagnostics Corp. — Product Code CGN

K031756 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY". The FDA issued a decision of Substantially Equivalent on June 25, 2003. 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.