510(k) K244044
- Device
- PBC Separator with Selux AST System
- Applicant
- Selux Diagnostics, Inc.
- 510(k) number
- K244044
- Product code
- QZX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-03-28
- Date received
- 2024-12-30
- Regulation
- 866.1650
- Classification name
- Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Carrene Plummer
- Address
- 56 Roland St. Suite 206 Charlestown MA US 02129 02129
FDA Registration Numbers
- 3035367039
- 2030652