FDA applicant
Ekf-Diagnostic GmbH
FDA records 5 decisions for Ekf-Diagnostic GmbH (Barleben, DE) from 2003 to 2020: 5 510(k) clearances. Most are in product codes GKR (System, Hemoglobin, Automated) and LCP (Assay, Glycosylated Hemoglobin). Its devices cite 5 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Ekf Diagnostic GmbH”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ekf-Diagnostic GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Ekf-Diagnostic GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report