510(k) K932531

ORTHO-MUNE OKT 4 (CD4) MONOCLONAL ANTIBODY MURINE by Ortho Diagnostic Systems, Inc. — Product Code GKZ

K932531 is an FDA 510(k) premarket notification submitted by Ortho Diagnostic Systems, Inc. for the device "ORTHO-MUNE OKT 4 (CD4) MONOCLONAL ANTIBODY MURINE". The FDA issued a decision of Substantially Equivalent on April 26, 1995. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Ortho Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.