510(k) K022200 ยท GKZ Counter, Differential Cell
PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120
| Applicant | Abx Diagnostics, Montpellier, FR |
| Decision | Substantially Equivalent, Jul 29, 2002 |
| Received | Jul 5, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K022200
| 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 |
| Aug 13, 2004 | ABX Diagnostics Inc PENTRA 120 and PENTRA 120 Retic Hematology Analyzer Terminated |
GJH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.