
Ortho Diagnostic Systems, Inc.
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ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE) is an FDA 510(k)-cleared medical device (K951100) manufactured by Ortho Diagnostic Systems, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 12, 1996. Regulation: 8.