510(k) K003677 ยท GKZ Counter, Differential Cell
ABX PENTRA 60C+ HEMATOLOGY ANALYZER
| Applicant | Abx Diagnostics, Irvine CA, US |
| Decision | Substantially Equivalent, Dec 26, 2000 |
| Received | Nov 29, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K003677
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2003 | ABX Diagnostics Inc ABX Diagnostices Pentra 60C+ Hematology Analyzer Terminated |
GKZ | None listed |
| Feb 25, 2003 | Beckman Coulter Inc AcT 5 diff Cap Pierce Hematology Analyzer
864.5220 Automated differential cell counter Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.