# K121467: Eurotrol Hematocrit Control

- Pathway: 510(k) (Traditional)
- Applicant: Eurotrol B.V.
- Decided: May 10, 2013 after 358 days
- Product code: GLK (Control, Hematocrit)
- 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 K955630 (1996). 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)
- K955630: Rna Medical Hemat Control, Bionostics, Inc. (1996) Summary page 1.

## Indications for use
Eurotrol Hct Control is an assayed hematocrit reference material, to verify the precision and accuracy of the epoc® Blood Analysis System for the measurement of hematocrit. Eurotrol Hct Control is for in vitro diagnostic use only. epoc® Hematocrit Verification Fluids is an assayed hematocrit reference material, to verify the precision and accuracy of the epoc® Blood Analysis System for the measurement of hematocrit. epoc® Hematocrit Verification Fluids is for in vitro diagnostic use only.

Source page: https://510kreport.com/device/K121467
Methodology: https://510kreport.com/methodology