# K163534: Lumipulse G FSH-N Calibrators

- Pathway: 510(k) (Abbreviated)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: Jan 13, 2017 after 28 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
Longest line of descent: 2 generations back to K003409 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012399: Modification to Elecsys FSH II Calset, Roche Diagnostics Corp. (2001) Summary page 4.

## Indications for use
Lumipulse G FSH-N Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G FSH-N on the LUMIPULSE G System.

Source page: https://510kreport.com/device/K163534
Methodology: https://510kreport.com/methodology