T2CANDIDA AND T2DX INSTRUMENT— 510(k) DEN140019
UnknownT2biosystems, Inc.
FDA 510(k) clearance DEN140019 for T2CANDIDA AND T2DX INSTRUMENT, Unknown on 2014-09-22. Applicant: T2biosystems, Inc.. Device class: 2.
Clearance details
- Applicant
- T2biosystems, Inc.
- Product code
- Code PII
- Device class
- Class 2
- Regulation
- 21 CFR 866.3960
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Lexington, MA, US
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