510(k) K071143 ยท GKZ Counter, Differential Cell
BD TRITEST CD3/CD4/CD45, MODEL 340383
| Applicant | Bd Biosciences, San Jose CA, US |
| Decision | Substantially Equivalent, Jun 6, 2007 |
| Received | Apr 24, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071143
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2016 | Becton, Dickinson and Company, BD Biosciences BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD);
Catalog number 340383.
Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium azide.
Hematology:
BD Tritest CD3 fluorescein isot Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.