Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in GermanyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of EKF DiagnosticsLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list EKF Diagnostic with 5 510(k) clearances. The most recent is a 510(k) clearance dated Jun 12, 2020: Hemo Control (optional Add Pack Hemo Control DM).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jun 12, 2020 | Hemo Control (optional Add Pack Hemo Control DM)K200909 · GKR | 510(k) clearances |
| Feb 16, 2019 | Quo-Test A1c SystemK180509 · LCP | 510(k) clearances |
| Apr 6, 2018 | DiaSpect Tm, DiaSpect Tm CuvettesK172173 · GKR | 510(k) clearances |
| Mar 4, 2011 | EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE WK110393 · GKR | 510(k) clearances |
| Sep 24, 2003 | EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEMK031898 · GKR | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
