Company ยท DE
Ekf-Diagnostic GmbH
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2020. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 12, 2020 | K200909 | Hemo Control (optional Add Pack Hemo Control DM) Ekf-Diagnostic GmbH, DE | GKR |
| Feb 16, 2019 | K180509 | Quo-Test A1c System Ekf-Diagnostic GmbH, DE | LCP |
| Apr 6, 2018 | K172173 | DiaSpect Tm, DiaSpect Tm Cuvettes Ekf-Diagnostic GmbH, DE | GKR |
| Mar 4, 2011 | K110393 | EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W Ekf-Diagnostic GmbH | GKR |
| Sep 24, 2003 | K031898 | EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM Ekf Diagnostic GmbH | GKR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||