510(k) K173536
- Device
- T2Candida 1.1 Panel
- Applicant
- T2 Biosystems, Inc.
- 510(k) number
- K173536
- Product code
- PII
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-12-12
- Date received
- 2017-11-15
- Regulation
- 866.3960
- Classification name
- Candida Species Nucleic Acid Detection System
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Anne Marie Whalen
- Address
- 101 Hartwell Ave. Lexington MA US 02421 02421
FDA Registration Numbers#
- 3004613294
- 3010749841
- 1627497
Source Documents#
Other 510(k) Records For Product Code PII #
Legacy Summary#
summary
FDA Review#
Decision Summary