# K970126: Access Estradiol Reagents on the Access Immunoassay Analyzer (33550,33540,33545)

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Feb 25, 1997 after 42 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Abbott IMx® Estradiol Kit: named in the summary without a submission number

## Most influential descendants
- K080166: Access Estradiol Calibrators on the Access Immunoassay Systems, Model 33545 (2008), 0 descendants of its own

## Indications for use
The ACCESS® Estradiol assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of Estradiol levels in human serum using the ACCESS® Immunoassay System.

Source page: https://510kreport.com/device/K970126
Methodology: https://510kreport.com/methodology