# K935612: Axsym Follicle Stimulating Hormone (FSH)

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 21, 1994 after 211 days
- Product code: CGJ (Radioimmunoassay, Follicle-Stimulating Hormone)
- Device class: 1
- Regulation: 21 CFR 862.1300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K032002: Fertell Female Fertility Test (2003), 1 descendant of its own
- K070484: Quantrx Female Fertility Test (2007), 0 descendants of its own

## Recalls of this device
- Sep 7, 2006 · Not classified · Z-0023-2007: Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient resu

Source page: https://510kreport.com/device/K935612
Methodology: https://510kreport.com/methodology