510(k) K951100 ยท GKZ Counter, Differential Cell
ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE)
| Applicant | Ortho Diagnostic Systems, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, May 13, 1996 |
| Received | Mar 10, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951100
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.