510(k) K913305 ยท GKZ Counter, Differential Cell
CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER
| Applicant | Unipath , Ltd., Mountain View CA, US |
| Decision | Substantially Equivalent, Nov 22, 1991 |
| Received | Jul 25, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913305
| 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.