510(k) K092693

VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS by Viramed Biotech AG — Product Code LSR

K092693 is an FDA 510(k) premarket notification submitted by Viramed Biotech AG for the device "VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS". The FDA issued a decision of Substantially Equivalent on November 25, 2009. 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.