510(k) K971007

LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M) by Mrl Diagnostics — Product Code LSR

K971007 is an FDA 510(k) premarket notification submitted by Mrl Diagnostics for the device "LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)". The FDA issued a decision of Substantially Equivalent on June 1, 1998. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. Mrl Diagnostics has at least 6 other 510(k) clearances on record.