510(k) K964754 ยท GKZ Counter, Differential Cell
ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE
| Applicant | Ortho Diagnostic Systems, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Jan 22, 1997 |
| Received | Nov 27, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964754
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.