Sysmex XR-Series (XR-10) Automated Hematology Analyzer (K250943)
Description
Sysmex XR-Series (XR-10) Automated Hematology Analyzer by Sysmex America, Inc., an FDA 510(k) cleared hematology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250943
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Sysmex XR-Series (XR-10) Automated Hematology Analyzer (K250943) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K141964 | XN CHECK | Streck | 2014 |
| K112605 | SYSMEX XN-SERIES | Sysmex America, Inc. | 2012 |
| K071967 | SYSMEX XE-5000 | Sysmex America, Inc. | 2007 |
Trace the full predicate network for K250943
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.