510(k) K213987

ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls by Biokit, S.A. — Product Code MXJ

K213987 is an FDA 510(k) premarket notification submitted by Biokit, S.A. for the device "ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls". The FDA issued a decision of Substantially Equivalent on September 20, 2023. 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. Biokit, S.A. has at least 10 other 510(k) clearances on record.