510(k) K951632

ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE) by Ortho Diagnostic Systems, Inc. — Product Code GKZ

K951632 is an FDA 510(k) premarket notification submitted by Ortho Diagnostic Systems, Inc. for the device "ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)". The FDA issued a decision of Substantially Equivalent on March 6, 1997. 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.