510(k) K243575

ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls by Biokit, S.A. — Product Code MYF

K243575 is an FDA 510(k) premarket notification submitted by Biokit, S.A. for the device "ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls". The FDA issued a decision of Substantially Equivalent on February 12, 2025. 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. Biokit, S.A. has at least 10 other 510(k) clearances on record.