510(k) K050719 ยท GKZ Counter, Differential Cell
ABX PENTRA DX 120: OPTION SPS EVOLUTION
| Applicant | Horiba Abx, Montpellier, FR |
| Decision | Substantially Equivalent, Apr 26, 2005 |
| Received | Mar 21, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050719
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2006 | ABX Diagnostics Inc ABX Pentra 120,120R,120DX, automated 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.