510(k) K950482 ยท GKZ Counter, Differential Cell
ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE)
| Applicant | Ortho Diagnostic Systems, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, May 10, 1996 |
| Received | Feb 3, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950482
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.