# K021924: Medica Easyqc Hematocrit Control

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Jun 24, 2002 after 13 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
Medica EasyQC Hematocrit Control assayed controls are intended to be used to monitor and evaluate the analytical performance of the Medica EasyStat for the measurement of hematocrit by conductivity.

Source page: https://510kreport.com/device/K021924
Methodology: https://510kreport.com/methodology