K230878
- 510(k) number
- K230878
- Device name
- QScout Lab; QScout RLD
- Applicant
- Ad Astra Diagnostics, Inc. NC · US
- Product code
- GKZ — Counter, Differential Cell
- Decision date
- 2023-11-14
- Date received
- 2023-03-30
- 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: K230878.pdf
Official FDA record: K230878
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.