# K973901: 17 B-Estradiol (Elisa)

- Pathway: 510(k) (Traditional)
- Applicant: Kmi Diagnostics, Inc.
- Decided: Nov 24, 1997 after 41 days
- Product code: CHP (Radioimmunoassay, Estradiol)
- Device class: 1
- Regulation: 21 CFR 862.1260
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The IBL Estradiol ELISA test kit is intended for the in vitro determination of cstradiol, an estrogenic steroid, in human serum and piasma. Estradiol measurements are used in the dugnosticsand treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.

Source page: https://510kreport.com/device/K973901
Methodology: https://510kreport.com/methodology