510(k) K071967 ยท GKZ Counter, Differential Cell
SYSMEX XE-5000
| Applicant | Sysmex America, Inc., Mundelein IL, US |
| Decision | Substantially Equivalent, Nov 20, 2007 |
| Received | Jul 16, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071967
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2012 | Sysmex America, Inc. Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #063-759 Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.