510(k) K112343

TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS by Siemens Healthcare Diagnostics, Inc. — Product Code LIP

K112343 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS". The FDA issued a decision of Substantially Equivalent on January 20, 2012. The device falls under product code LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum), a Class II device regulated under 21 CFR 866.3830. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.