FDA 510(k) Applications Submitted by PATRICK A ROCHE

FDA 510(k) Number Submission Date Device Name Applicant
K950482 02/03/1995 ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE) ORTHO DIAGNOSTIC SYSTEMS, INC.
K950568 02/08/1995 ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE) ORTHO DIAGNOSTIC SYSTEMS, INC.
K950625 02/10/1995 ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE) ORTHO DIAGNOSTIC SYSTEMS, INC.
K951100 03/10/1995 ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE) ORTHO DIAGNOSTIC SYSTEMS, INC.
K935720 11/30/1993 ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM ORTHO DIAGNOSTIC SYSTEMS, INC.


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