K223493
- 510(k) number
- K223493
- 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
- 2024-02-15
- Date received
- 2022-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 1.9 MB · U.S. public domain
Also available from FDA: K223493.pdf
Official FDA record: K223493
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.