# K970386: Acs Estadiol-6 II

- Pathway: 510(k) (Traditional)
- Applicant: Chiron Diagnostics Corp.
- Decided: Jun 4, 1997 after 121 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 Chiron Diagnostics ACS:180 Estradiol-6 1l Assay is for the quantitative determination of estradiel in serum and to aid in assessing ovarian function and in the monitoring of follicular development using the Chiron Diagnostics ACS;180 automated chemiluminescence systems.

Source page: https://510kreport.com/device/K970386
Methodology: https://510kreport.com/methodology