# K972720: Follicle Stimulating Hormone (FSH) Microplate Elisa (425-300)

- Pathway: 510(k) (Traditional)
- Applicant: Monobind
- Decided: Sep 2, 1997 after 43 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ciba Corning ACS 180 chemiluminescence (ICMA) test: named in the summary without a submission number

## Indications for use
The quantitative determination of follicle stimulating hormone (FSH) concentration in human serum and plasma by a microplate enzymeimmunoassay. Measurements of follicle-stimulating hormone are used in the diagnosis of pituitary gland and gonadotropin disorders.

Source page: https://510kreport.com/device/K972720
Methodology: https://510kreport.com/methodology