510(k) K092322

ELECSYS RUBELLA IGM IMMUNOASSAY by Roche Diagnostics — Product Code LFX

K092322 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "ELECSYS RUBELLA IGM IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on March 12, 2010. The device falls under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Roche Diagnostics has at least 10 other 510(k) clearances on record.