510(k) K244044
K244044 is an FDA 510(k) premarket notification submitted by Selux Diagnostics, Inc. for the device "PBC Separator with Selux AST System". The FDA issued a decision of Substantially Equivalent on March 28, 2025. The device falls under product code QZX (Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing), a Class II device regulated under 21 CFR 866.1650. Selux Diagnostics, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 2025
- Date Received
- December 30, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
- Device Class
- Class II
- Regulation Number
- 866.1650
- Review Panel
- MI
- Submission Type
Processing device that includes associated reagents, when applicable, that is intended to recover microbes from positive blood cultures for inoculum preparation. The prepared inoculum is intended for subsequent use in antimicrobial susceptibility testing.