510(k) K992511 ยท GKZ Counter, Differential Cell
ABX PENTRA 60 HEMATOLOGY ANALYZER
| Applicant | Abx Diagnostics, Irvine CA, US |
| Decision | Substantially Equivalent, Oct 15, 1999 |
| Received | Jul 27, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992511
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2003 | Beckman Coulter Inc Coulter AcT 5diff Open Vial Hematology Analyzers
Part Numbers: 6605580, 6605581, 6605604 Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.