# K182744: HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High

- Pathway: 510(k) (Traditional)
- Applicant: Eurotrol B.V.
- Decided: Feb 1, 2019 after 126 days
- Product code: GGM (Control, Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.8625
- 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 K964052 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964052: Hemocue Hemotrol, Direct Solutions (1996) Summary page 4.

## Most influential descendants
- K192842: HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High (2019), 0 descendants of its own

## Indications for use
HemoTrol® WB is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue ® Hb 301 and the HemoCue ® Hb 801 System. HemoTrol® WB is intended for the quantitative determination of hemoglobin.

Source page: https://510kreport.com/device/K182744
Methodology: https://510kreport.com/methodology