Chrysalis Intelligence · Sponsors · T2biosystems, Inc.

T2biosystems, Inc.

Lexington, MA, US · 3 510(k) clearances

Total clearances
3
2023-09-15 → 2024-09-13
Last 12 months
0
Product codes
3
Most recent
2024-09-13
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
PII Candida Species Nucleic Acid Detection System Class II Microbiology 1 2024-09-13
QBX 1 2024-02-08
QVR Multiplex Nucleic Acid Detection System For Biothreat Agents Class II Immunology 1 2023-09-15
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2024-09-13 K234063 T2Candida 1.1 Panel PII Class II Microbiology
2024-02-08 K233184 T2Bacteria® Panel QBX
2023-09-15 K231336 T2 Biothreat Panel QVR Class II Immunology