510(k) K072617

ELECSYS RUBELLA IGG IMMUNOASSAY by Roche Diagnostics Corp. — Product Code LFX

K072617 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ELECSYS RUBELLA IGG IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on December 5, 2008. The device falls under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.