510(k) K965053 ยท GKZ Counter, Differential Cell
TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP; TRUCOUNT ABSOLUTE COUNT TUBES
| Applicant | Becton Dickinson Immunocytometry Systems, San Jose CA, US |
| Decision | Substantially Equivalent, Nov 21, 1997 |
| Received | Dec 18, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965053
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.