PBC Separator with Selux AST System— 510(k) K244044
Substantially EquivalentSelux Diagnostics, Inc.
FDA 510(k) clearance K244044 for PBC Separator with Selux AST System, Substantially Equivalent on 2025-03-28. Applicant: Selux Diagnostics, Inc..
Clearance details
- Applicant
- Selux Diagnostics, Inc.
- Product code
- Code QZX
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Charlestown, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.