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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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