Class Class II
Access hsTnI (K242870)
Description
Access hsTnI by Beckman Coulter, Inc., an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242870
Clearance Date2025-06-16
Clearance TypeTraditional
Product CodeMMI
Regulation Number862.1215
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242870
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. Access hsTnI (K242870) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230648 | Access hsTnI | Beckman Coulter, Inc. | 2023 |
Trace the full predicate network for K242870
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.