Atellica® IM High-Sensitivity Troponin I (TnIH) (K241165)
Description
Atellica® IM High-Sensitivity Troponin I (TnIH) by Siemens Healthcare Diagnostics, Inc., an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241165
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. Atellica® IM High-Sensitivity Troponin I (TnIH) (K241165) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K062838 | VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRA... | Ortho-Clinical Diagnostics | 2006 |
Trace the full predicate network for K241165
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.