Class Class II
Alinity h-series System (K243283)
Description
Alinity h-series System by Abbott Laboratories, an FDA 510(k) cleared hematology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243283
Clearance Date2025-02-20
Clearance TypeTraditional
Product CodeGKZ
Regulation Number864.5220
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243283
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. Alinity h-series System (K243283) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220031 | Alinity h-series System | Abbott Laboratories | 2023 |
| K112605 | SYSMEX XN-SERIES | Sysmex America, Inc. | 2012 |
Trace the full predicate network for K243283
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.