Ortho Diagnostic Systems, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 126
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K951459 | ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE | July 14, 1997 |
| K951632 | ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE) | March 6, 1997 |
| K964754 | ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE | January 22, 1997 |
| K963902 | QUANTITATIVE FIBRINOGEN ASSAY | November 29, 1996 |
| K950625 | ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE) | May 13, 1996 |
| K951100 | ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE) | May 13, 1996 |
| K950568 | ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE) | May 13, 1996 |
| K950482 | ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE) | May 10, 1996 |
| K935720 | ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM | May 9, 1996 |
| K954570 | ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM | April 30, 1996 |
| K955638 | SYNTHAFAX APTT REAGENT | April 23, 1996 |
| K953981 | SYNTHASIL APTT REAGENT | November 30, 1995 |
| K941192 | ORTHO ALT MICROWELL TEST SYSTEM | May 16, 1995 |
| K940209 | ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL | May 11, 1995 |
| K935748 | ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT | April 26, 1995 |
| K932530 | ORTHO-MUNE OKT 3 MONOCLONAL ANTIBODY (MURINE) | April 26, 1995 |
| K941713 | ORTHO-MUNE 0KT 11 (CD2) MONOCLONAL ANTIBODY (MURINE) | April 26, 1995 |
| K932532 | ORTHO-MUNE OKT8 (CD8) MONOCLONAL ANTIBODY (MURINE) | April 26, 1995 |
| K932531 | ORTHO-MUNE OKT 4 (CD4) MONOCLONAL ANTIBODY MURINE | April 26, 1995 |
| K931443 | ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS | November 5, 1993 |