510(k) K980858 ยท GKZ Counter, Differential Cell
MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION
| Applicant | Becton Dickinson Immunocytometry Systems, San Jose CA, US |
| Decision | Substantially Equivalent, May 22, 1998 |
| Received | Mar 5, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980858
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2015 | BD Biosciences, Systems & Reagents BD FACSCalibur;
Catalog Numbers 342973, 342975, 34976
In vitro Diagnostics Use. Terminated |
OYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.