K243348
- 510(k) number
- K243348
- Device name
- Athelas Home
- Applicant
- Athelas, Inc. CA · US
- Product code
- GKZ — Counter, Differential Cell
- Decision date
- 2026-02-06
- Date received
- 2024-10-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 3.4 MB · U.S. public domain
Also available from FDA: K243348.pdf
Official FDA record: K243348
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.