510(k) K880636 ยท GKL Counter, Cell, Automated (Particle Counter)
RETICCOUNT SOFTWARE
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, Mar 21, 1988 |
| Received | Feb 16, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880636
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2016 | Becton, Dickinson and Company, BD Biosciences BD-Retic-Count Reticulocyte Reagent System;
Hematology: Used for in vitro diagnostics Terminated |
GKL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.