510(k) K231336
K231336 is an FDA 510(k) premarket notification submitted by T2biosystems, Inc. for the device "T2 Biothreat Panel". The FDA issued a decision of Substantially Equivalent on September 15, 2023. The device falls under product code QVR (Multiplex Nucleic Acid Detection System For Biothreat Agents), a Class II device regulated under 21 CFR 866.4000. T2biosystems, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 15, 2023
- Date Received
- May 8, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Multiplex Nucleic Acid Detection System For Biothreat Agents
- Device Class
- Class II
- Regulation Number
- 866.4000
- Review Panel
- MI
- Submission Type
A multiplex nucleic acid detection system for biothreat agents is a qualitative in vitro diagnostic test for detection and identification of nucleic acids from biothreat pathogens in human clinical specimens