T2 Biothreat Panel— 510(k) K231336
Substantially EquivalentT2biosystems, Inc.
FDA 510(k) clearance K231336 for T2 Biothreat Panel, Substantially Equivalent on 2023-09-15. Applicant: T2biosystems, Inc.. Device class: 2.
Clearance details
- Applicant
- T2biosystems, Inc.
- Product code
- Code QVR
- Device class
- Class 2
- Regulation
- 21 CFR 866.4000
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lexington, MA, US
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