510(k) K904253 ยท GKZ Counter, Differential Cell
ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY
| Applicant | Ortho Diagnostic Systems, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, May 20, 1991 |
| Received | Sep 14, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904253
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.