Class Class II
i-STAT CG4+ cartridge with the i-STAT 1 System (K244014)
Description
i-STAT CG4+ cartridge with the i-STAT 1 System by Abbott Point of Care, Inc., an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK244014
Clearance Date2025-05-02
Clearance TypeTraditional
Product CodeCHL
Regulation Number862.1120
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K244014
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 CG4+ cartridge with the i-STAT 1 System (K244014) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223857 | i-STAT G3+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023 |
Trace the full predicate network for K244014
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.