510(k) K904390 ยท GKZ Counter, Differential Cell
ANTI-HUMAN LEU-2A (CD8) PE
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, Dec 17, 1990 |
| Received | Sep 25, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904390
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 20, 2015 | BD Biosciences, Systems & Reagents CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046.
Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymph Terminated |
GKL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.