510(k) K992875 ยท GKZ Counter, Differential Cell
SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER
| Applicant | Sysmex Corp., Long Grove IL, US |
| Decision | Substantially Equivalent, Nov 9, 1999 |
| Received | Aug 26, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992875
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2012 | Sysmex America, Inc. Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #983-134 Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.