510(k) K991062

QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024 by Immunetics, Inc. — Product Code LSR

K991062 is an FDA 510(k) premarket notification submitted by Immunetics, Inc. for the device "QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024". The FDA issued a decision of Substantially Equivalent on September 21, 1999. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. Immunetics, Inc. has at least 3 other 510(k) clearances on record.