510(k) K890053

MARDX LYME DISEASE IGG IFA TEST SYSTEM by Mardx Diagnostics, Inc. — Product Code LSR

K890053 is an FDA 510(k) premarket notification submitted by Mardx Diagnostics, Inc. for the device "MARDX LYME DISEASE IGG IFA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on April 18, 1989. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. Mardx Diagnostics, Inc. has at least 7 other 510(k) clearances on record.