K243283
- 510(k) number
- K243283
- Device name
- Alinity h-series System
- Applicant
- Abbott Laboratories CA · US
- Product code
- GKZ — Counter, Differential Cell
- Decision date
- 2025-02-20
- Date received
- 2024-10-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243283.pdf
Official FDA record: K243283
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.