# K890135: Imx Follicle Stimulating Hormone (FSH)

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Feb 10, 1989 after 28 days
- Product code: CGJ (Radioimmunoassay, Follicle-Stimulating Hormone)
- Device class: 1
- Regulation: 21 CFR 862.1300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

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

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

## Most influential descendants
- K032458: Abbott Architect Estradiol Calibrators; Abbott Imx Estradiol Calibrator; Abbott Imx Estradiol Mode 1 Calibrator; Abbott (2003), 2 descendants of its own
- K111023: Abbott Architect LH Calibrators (2011), 1 descendant of its own
- K163521: Lumipulse G LH Calibrators (2017), 0 descendants of its own

Source page: https://510kreport.com/device/K890135
Methodology: https://510kreport.com/methodology