The following data is part of a premarket notification filed by T2 Biosystems, Inc. with the FDA for T2bacteria Panel.
| Device ID | K172708 |
| 510k Number | K172708 |
| Device Name: | T2Bacteria Panel |
| Classification | Direct Blood Bacterial Nucleic Acid Detection System |
| Applicant | T2 Biosystems, Inc. 101 Hartwell Avenue Lexington, MA 02421 |
| Contact | Tom Lowery |
| Correspondent | Tom Lowery T2 Biosystems, Inc. 101 Hartwell Avenue Lexington, MA 02421 |
| Product Code | QBX |
| CFR Regulation Number | 866.3960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-08 |
| Decision Date | 2018-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M70890080710 | K172708 | 000 |
| M70880073423 | K172708 | 000 |
| M70885080730 | K172708 | 000 |
| M70880080720 | K172708 | 000 |