510(k) DEN140019
- Device
- T2CANDIDA AND T2DX INSTRUMENT
- Applicant
- T2biosystems, Inc.
- 510(k) number
- DEN140019
- Product code
- PII
- Decision
- Unknown (DENG)
- Decision date
- 2014-09-22
- Date received
- 2014-05-27
- Regulation
- 866.3960
- Classification name
- Candida Species Nucleic Acid Detection System
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Sarah Kalil
- Address
- 101 Hartwell Ave. Lexington MA US 02421 02421
FDA Registration Numbers#
- 3004613294
- 3010749841
- 1627497
Source Documents#
510(k) summary PDF not indicated by FDA