510(k) K220016

Viramed Borrela All-In-One ViraChip Test Kit by Viramed Biotech AG — Product Code LSR

K220016 is an FDA 510(k) premarket notification submitted by Viramed Biotech AG for the device "Viramed Borrela All-In-One ViraChip Test Kit". The FDA issued a decision of Substantially Equivalent on August 19, 2022. 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.