510(k) K032677 ยท GKL Counter, Cell, Automated (Particle Counter)
SYSMEX POCH-100I
| Applicant | Sysmex America, Inc., Mundelein IL, US |
| Decision | Substantially Equivalent, Feb 11, 2004 |
| Received | Aug 29, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032677
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2013 | Sysmex America Inc pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. W Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.