510(k) K964787

MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM by Mardx Diagnostics, Inc. — Product Code LLL

K964787 is an FDA 510(k) premarket notification submitted by Mardx Diagnostics, Inc. for the device "MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on April 8, 1997. The device falls under product code LLL (Extractable Antinuclear Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Mardx Diagnostics, Inc. has at least 7 other 510(k) clearances on record.