510(k) K923903

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA by Biomerieux Vitek, Inc. — Product Code LJY

K923903 is an FDA 510(k) premarket notification submitted by Biomerieux Vitek, Inc. for the device "VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA". The FDA issued a decision of Substantially Equivalent on August 9, 1993. The device falls under product code LJY (Enzyme Linked Immunoabsorbent Assay, Mumps Virus), a Class I device regulated under 21 CFR 866.3380. Biomerieux Vitek, Inc. has at least 10 other 510(k) clearances on record.