# K011389: Hemoglobin F & A2 Control (Beta-Thalassaemia Control)

- Pathway: 510(k) (Traditional)
- Applicant: Canterbury Health Laboratories
- Decided: Jun 21, 2001 after 45 days
- Product code: JCM (Control, Hemoglobin, Abnormal)
- Device class: 2
- Regulation: 21 CFR 864.7415
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K053031: Extendsure Hbfasc Control (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K011389
Methodology: https://510kreport.com/methodology