510(k) K991539 ยท GKZ Counter, Differential Cell
EXCELL 22
| Applicant | Mwi, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Jul 1, 1999 |
| Received | May 3, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991539
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 9, 2007 | Drew Scientific Group PLC Bayer Advia 70 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX. Terminated |
GKZ | None listed |
| Jan 9, 2007 | Drew Scientific Group PLC Drew Excell 22 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX. Terminated |
GKZ | None listed |
| Jan 5, 2007 | Drew Scientific Group PLC Bayer Advia 70 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX. Terminated |
GKZ | None listed |
| Jan 5, 2007 | Drew Scientific Group PLC Drew Excell 22 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX. Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.