510(k) K220924

Elecsys HSV-2 IgG (08948887160) by Roche Diagnostics — Product Code MYF

K220924 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys HSV-2 IgG (08948887160)". The FDA issued a decision of Substantially Equivalent on October 12, 2022. The device falls under product code MYF (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2), a Class II device regulated under 21 CFR 866.3305. Roche Diagnostics has at least 10 other 510(k) clearances on record.