Ekf Diagnostic GmbH
BARLEBEN/MADGEBURG Saxony-Anhalt, DE
EKF DIAGNOSTIC GMBH appears in FDA device records in BARLEBEN/MADGEBURG Saxony-Anhalt, DE. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Ekf Diagnostic GmbH between 2003 and 2020. The busiest year on record is 2003, with 1. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2011 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K200909 | Hemo Control (optional Add Pack Hemo Control DM) | GKR | Substantially Equivalent | |
| K180509 | Quo-Test A1c System | LCP | Substantially Equivalent | |
| K172173 | DiaSpect Tm, DiaSpect Tm Cuvettes | GKR | Substantially Equivalent | |
| K110393 | EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W | GKR | Substantially Equivalent | |
| K031898 | EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM | GKR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004838836 | 3004838836 | EKF DIAGNOSTIC GMBH | EBENDORFER CHAUSEE 3, BARLEBEN/MADGEBURG Saxony-Anhalt D-39179 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain