510(k) K993724

HSV-2 ELISA IGG, MODEL EL0920G by Mrl Diagnostics — Product Code MYF

K993724 is an FDA 510(k) premarket notification submitted by Mrl Diagnostics for the device "HSV-2 ELISA IGG, MODEL EL0920G". The FDA issued a decision of Substantially Equivalent on February 1, 2000. 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. Mrl Diagnostics has at least 6 other 510(k) clearances on record.