510(k) K954570 ยท GKZ Counter, Differential Cell
ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM
| Applicant | Ortho Diagnostic Systems, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Apr 30, 1996 |
| Received | Oct 2, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954570
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.