510(k) K953682

IMMUNO DOT BORRELIA DOT BLOT G TEST by Genbio — Product Code LSR

K953682 is an FDA 510(k) premarket notification submitted by Genbio for the device "IMMUNO DOT BORRELIA DOT BLOT G TEST". The FDA issued a decision of Substantially Equivalent on May 3, 1996. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. Genbio has at least 9 other 510(k) clearances on record.