# K200909: Hemo Control (optional Add Pack Hemo Control DM)

- Pathway: 510(k) (Special)
- Applicant: Ekf-Diagnostic GmbH
- Decided: Jun 12, 2020 after 67 days
- Product code: GKR (System, Hemoglobin, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5620
- 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 K031898 (2003). 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)
- K031898: Ekf Diagnostic Hemo Control Hemoglobin Measurement System, Ekf Diagnostic GmbH (2003) Summary page 5.

## Indications for use
Hemo Control is intended to be used for the quantitative determination of hemoglobin (Hb) concentrations in human blood. The Hemo Control Hemoglobin Microcuvettes are intended to be used with the Hemo Control photometer for the quantitative determination of hemoglobin (Hb) concentrations in human blood. For in-vitro diagnostic use only.

Source page: https://510kreport.com/device/K200909
Methodology: https://510kreport.com/methodology