Class Class II
Alkaline Phosphatase (K240468)
Description
Alkaline Phosphatase by Abbott Laboratories Diagnostics Division, an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240468
Clearance Date2024-10-16
Clearance TypeSpecial
Product CodeCJE
Regulation Number862.1050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240468
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. Alkaline Phosphatase (K240468) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K023807 | MODIFICATION TO ALKP | Abbott Laboratories | 2002 |
Trace the full predicate network for K240468
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.