510(k) K172708
- Device
- T2Bacteria Panel
- Applicant
- T2 Biosystems, Inc.
- 510(k) number
- K172708
- Product code
- QBX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-05-24
- Date received
- 2017-09-08
- Regulation
- 866.3960
- Classification name
- Direct Blood Bacterial Nucleic Acid Detection System
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Tom Lowery
- Address
- 101 Hartwell Ave. Lexington MA US 02421 02421
Source Documents#
Other 510(k) Records For Product Code QBX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233184 | T2Bacteria® Panel | T2biosystems, Inc. | 2024-02-08 |
Legacy Summary#
summary
FDA Review#
Decision Summary