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 |