# K003409: Elecsys FSH Calset II

- Pathway: 510(k) (Abbreviated)
- Applicant: Roche Diagnostics Corp.
- Decided: Jan 26, 2001 after 85 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- 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
- K012399: Modification to Elecsys FSH II Calset (2001), 1 descendant of its own
- K163534: Lumipulse G FSH-N Calibrators (2017), 0 descendants of its own

Source page: https://510kreport.com/device/K003409
Methodology: https://510kreport.com/methodology