T2Candida 1.1 Panel— 510(k) K173536
Substantially EquivalentT2biosystems, Inc.
FDA 510(k) clearance K173536 for T2Candida 1.1 Panel, Substantially Equivalent on 2017-12-12. 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
- Substantially Equivalent
- Clearance type
- Special
- Location
- Lexington, MA, US
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