# K952559: Erythropoietin Immunoassay Kit

- Pathway: 510(k) (Traditional)
- Applicant: Nichols Institute
- Decided: May 29, 1996 after 362 days
- Product code: GGT (Assay, Erythropoietin)
- Device class: 2
- Regulation: 21 CFR 864.7250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K980737: Advantage Chemiluminescence Erythropoietin Immunoassay (1999), 3 descendants of its own
- K052223: Access Epo Assay (2006), 2 descendants of its own
- K240182: Access EPO (2024), 0 descendants of its own
- K183088: ADVIA Centaur Erythropoietin (EPO) assay (2019), 0 descendants of its own

Source page: https://510kreport.com/device/K952559
Methodology: https://510kreport.com/methodology