# K954048: Variant Hemoglobinopathy Program

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Nov 20, 1995 after 84 days
- Product code: GKA (Abnormal Hemoglobin Quantitation)
- 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
Longest line of descent: 1 generation back to K840011 (1984). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K840011: Resolve-HB, Isolab, Inc. (1984) Summary page 1.

## Indications for use
An aid in the detection of normal and abnormal hemoglobins by High Performance Liquid Chromatography.

Source page: https://510kreport.com/device/K954048
Methodology: https://510kreport.com/methodology