510(k) K231536
K231536 is an FDA 510(k) premarket notification submitted by Avails Medical, Inc. for the device "eQUANT System". The FDA issued a decision of Substantially Equivalent on February 8, 2024. 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.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 2024
- Date Received
- May 30, 2023
- 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.