510(k) K120625

ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV by Roche Diagnostics — Product Code MXJ

K120625 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV". The FDA issued a decision of Substantially Equivalent on July 25, 2012. The device falls under product code MXJ (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1), a Class II device regulated under 21 CFR 866.3305. Roche Diagnostics has at least 10 other 510(k) clearances on record.