510(k) K233184
K233184 is an FDA 510(k) premarket notification submitted by T2biosystems, Inc. for the device "T2Bacteria® Panel". The FDA issued a decision of Substantially Equivalent on February 8, 2024. The device falls under product code QBX (Direct Blood Bacterial Nucleic Acid Detection System), a Class II device regulated under 21 CFR 866.3960. T2biosystems, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 2024
- Date Received
- September 28, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Direct Blood Bacterial Nucleic Acid Detection System
- Device Class
- Class II
- Regulation Number
- 866.3960
- Review Panel
- MI
- Submission Type
Amplification, detection and identification of microbial pathogens directly from whole blood specimens