Class Class II
Alere NT-proBNP for Alinity i Reagent Kit (K241176)
Description
Alere NT-proBNP for Alinity i Reagent Kit by Axis-Shield Diagnostics, Ltd., an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241176
Clearance Date2025-01-16
Clearance TypeTraditional
Product CodeNBC
Regulation Number862.1117
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241176
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. Alere NT-proBNP for Alinity i Reagent Kit (K241176) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K092649 | ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CA... | Roche Diagnostics Corp. | 2010 |
Trace the full predicate network for K241176
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.