510(k) K051457 ยท JIX Calibrator, Multi-Analyte Mixture
SENTINEL PLASMAPROTEINS CAL 3X
| Applicant | Sentinel Ch. Srl, Milano, IT |
| Decision | Substantially Equivalent, Jul 25, 2005 |
| Received | Jun 2, 2005 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K051457
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2012 | Sysmex America, Inc. Sysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #053-23 Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.