# K012900: Access Unconjugated Estriol Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Oct 16, 2001 after 48 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
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) Beckman Coulter Access Unconjugated Estriol Calibrators: named in the summary without a submission number
- (no number) Beckman Coulter Access Ultrasensitive hGH Calibrators: named in the summary without a submission number

## Indications for use
The Access Unconjugated Estriol Calibrators set is a device intended for medical purposes for use in the Access Immunocassay System, to establish points of reference that are used in the determination of values in the measurement of estriol levels in human serum.

Source page: https://510kreport.com/device/K012900
Methodology: https://510kreport.com/methodology