FDA 510(k) Applications Submitted by ORTHO DIAGNOSTIC SYSTEMS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K963902 |
09/27/1996 |
QUANTITATIVE FIBRINOGEN ASSAY |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
| K955638 |
12/11/1995 |
SYNTHAFAX APTT REAGENT |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
| K951459 |
03/30/1995 |
ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
| K951632 |
04/07/1995 |
ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE) |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
| K954570 |
10/02/1995 |
ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
| K964754 |
11/27/1996 |
ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
| 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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