# Ekf-Diagnostic GmbH

- Location (FDA's records): Barleben, DE
- FDA decisions: 5 (2003–2020): 5 510(k) clearances
- Names in FDA's records: Ekf-Diagnostic GmbH (4); Ekf Diagnostic GmbH (1)
- Product codes: GKR (4), LCP (1)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Stanbio Laboratory: 2 (https://510kreport.com/company/stanbio-laboratory)
- Alere Technologies AS: 1 (https://510kreport.com/company/alere-technologies)

## Its most-cited devices
- K031898: Ekf Diagnostic Hemo Control Hemoglobin Measurement System (2003), cited by 2

## Recent decisions
- K200909: Hemo Control (optional Add Pack Hemo Control DM) (Jun 12, 2020)
- K180509: Quo-Test A1c System (Feb 16, 2019)
- K172173: DiaSpect Tm, DiaSpect Tm Cuvettes (Apr 6, 2018)
- K110393: Ekf- Diagnostic Hemo_Control Hemoglobin Measurement System; Ekf-Diagnostic Hemoglobin Microcuvettes (Modified Curvette W (Mar 4, 2011)
- K031898: Ekf Diagnostic Hemo Control Hemoglobin Measurement System (Sep 24, 2003)

Source page: https://510kreport.com/company/ekf-diagnostic