510(k) K955715 ยท GKZ Counter, Differential Cell
CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)
| Applicant | Abbott Laboratories, Santa Clara CA, US |
| Decision | Substantially Equivalent, Oct 8, 1996 |
| Received | Nov 30, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955715
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 29, 2007 | Abbott Laboratories Abbott CELL-DYN 3500 Hematology Analyzer Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.