510(k) K050590

ENZY-WELL SYPHILIS IGG, MODEL 91106 by Diesse Diagnostica Senese S.P.A. — Product Code LIP

K050590 is an FDA 510(k) premarket notification submitted by Diesse Diagnostica Senese S.P.A. for the device "ENZY-WELL SYPHILIS IGG, MODEL 91106". The FDA issued a decision of Substantially Equivalent on August 10, 2006. The device falls under product code LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum), a Class II device regulated under 21 CFR 866.3830. Diesse Diagnostica Senese S.P.A. has at least 1 other 510(k) clearance on record.