510(k) K820643

ORTHO SPECTRUM III & ORTHO-MUNE OK by Ortho Diagnostic Systems, Inc. — Product Code LIZ

K820643 is an FDA 510(k) premarket notification submitted by Ortho Diagnostic Systems, Inc. for the device "ORTHO SPECTRUM III & ORTHO-MUNE OK". The FDA issued a decision of Substantially Equivalent on July 14, 1982. The device falls under product code LIZ (Assay, T Lymphocyte Surface Marker), a Class II device regulated under 21 CFR 864.5220. Ortho Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.