510(k) K953683

MMUNO DOT BORRELIA DOT BLOT M TEST by Genbio — Product Code LSR

K953683 is an FDA 510(k) premarket notification submitted by Genbio for the device "MMUNO DOT BORRELIA DOT BLOT M 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.