Class Class II
T2Candida 1.1 Panel (K234063)
Description
T2Candida 1.1 Panel by T2biosystems, Inc., an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK234063
Clearance Date2024-09-13
Clearance TypeTraditional
Product CodePII
Regulation Number866.3960
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K234063
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. T2Candida 1.1 Panel (K234063) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K173536 | T2Candida 1.1 Panel | T2biosystems, Inc. | 2017 |
Trace the full predicate network for K234063
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.