510(k) K163504

Borrelia B31 ViraChip IgG Test Kit by Viramed Biotech AG — Product Code LSR

K163504 is an FDA 510(k) premarket notification submitted by Viramed Biotech AG for the device "Borrelia B31 ViraChip IgG Test Kit". The FDA issued a decision of Substantially Equivalent on July 12, 2017. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. Viramed Biotech AG has at least 6 other 510(k) clearances on record.