i-STAT hs-TnI cartridge with the i-STAT 1 System (K240984)
Description
i-STAT hs-TnI cartridge with the i-STAT 1 System by Abbott Point of Care, Inc., an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240984
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. i-STAT hs-TnI cartridge with the i-STAT 1 System (K240984) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231974 | PATHFAST®hs-cTnI-II | Phc Corporation | 2024 |
Trace the full predicate network for K240984
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.