K244044
- 510(k) number
- K244044
- Device name
- PBC Separator with Selux AST System
- Applicant
- Selux Diagnostics, Inc. MA · US
- Product code
- QZX — Positive Blood Culture Processor For Inoculum Prepar
- Decision date
- 2025-03-28
- Date received
- 2024-12-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 1.8 MB · U.S. public domain
Also available from FDA: K244044.pdf
Official FDA record: K244044
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.