# K840011: Resolve-HB

- Pathway: 510(k) (Traditional)
- Applicant: Isolab, Inc.
- Decided: Feb 4, 1984 after 31 days
- Product code: GKA (Abnormal Hemoglobin Quantitation)
- Device class: 2
- Regulation: 21 CFR 864.7415
- Recalls of this device: 2 (0 Class I)
- 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
- K954048: Variant Hemoglobinopathy Program (1995), 0 descendants of its own

## Recalls of this device
- Sep 14, 2004 · Not classified · Z-0047-05: The product insert for the test kits is incorrect with regard to the acceptable storage temperature for the Agarose IEF gel component. The kit and IEF gel labels indicate the correct storage temperatu
- Jun 29, 2004 · Not classified · Z-1158-04: Hemoglobin Test Kit Catholyte Solution generating false positive results, were distributed.

Source page: https://510kreport.com/device/K840011
Methodology: https://510kreport.com/methodology