510(k) K231214

LIAISON VZV IgG HT, LIAISON Control VZV IgG HT by DiaSorin, Inc. — Product Code LFY

K231214 is an FDA 510(k) premarket notification submitted by DiaSorin, Inc. for the device "LIAISON VZV IgG HT, LIAISON Control VZV IgG HT". The FDA issued a decision of Substantially Equivalent on October 27, 2023. The device falls under product code LFY (Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster), a Class II device regulated under 21 CFR 866.3900. DiaSorin, Inc. has at least 10 other 510(k) clearances on record.