# K192842: HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High

- Pathway: 510(k) (Traditional)
- Applicant: Eurotrol B.V.
- Decided: Nov 15, 2019 after 43 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: 2 generations back to K964052 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182744: HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High, Eurotrol B.V. (2019) Summary page 4.

## Indications for use
HemoTrol® Duo 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® Duo is intended for the quantitative determination of hemoglobin.

Source page: https://510kreport.com/device/K192842
Methodology: https://510kreport.com/methodology