Ortho Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE, ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE), ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE
126
Total
126
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ortho Diagnostic Systems, Inc. Hematology ✕
54 devices
Cleared
Jul 14, 1997
ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE
Hematology
837d
Cleared
Mar 06, 1997
ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)
Hematology
699d
Cleared
Jan 22, 1997
ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE
Hematology
56d
Cleared
Nov 29, 1996
QUANTITATIVE FIBRINOGEN ASSAY
Hematology
63d
Cleared
May 13, 1996
ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)
Hematology
460d
Cleared
May 13, 1996
ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)
Hematology
458d
Cleared
May 13, 1996
ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE)
Hematology
430d
Cleared
May 10, 1996
ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE)
Hematology
462d
Cleared
May 09, 1996
ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY...
Hematology
891d
Cleared
Apr 30, 1996
ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM
Hematology
211d
Cleared
Apr 23, 1996
SYNTHAFAX APTT REAGENT
Hematology
134d
Cleared
Nov 30, 1995
SYNTHASIL APTT REAGENT
Hematology
99d
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