Data / Medical devices / Germany / Ekf Diagnostic GMBH
Ekf Diagnostic GMBH: FDA-registered device maker in BARLEBEN/MADGEBURG Saxony-Anhalt, Germany, 4 510(k) clearances
Ekf Diagnostic GMBH is registered with the FDA (registration 3004838836) in BARLEBEN/MADGEBURG Saxony-Anhalt, Germany. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 12, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004838836
- Address
- Ebendorfer Chausee 3, BARLEBEN/MADGEBURG Saxony-Anhalt, Germany, D-39179
- Owner or operator
- EKF DIAGNOSTIC GMBH (9057009)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- May 12, 2008
- Registered through
- 2026
- Brand names listed
- Consult Hb Control Solution High Level, Consult Hb Control Solution Low Level, Consult Hb Control Solution Medium Level, Consult diagnostics Hemoglobin Analyzer, Consult diagnostics Hemoglobin Cuvettes, DiaSpect Control HBT1, DiaSpect Control HBT2, DiaSpect Control HBT3 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calculator/Data Processing Module, For Clinical Use | JQP | 1 | Manufacturer | accessdata.fda.gov |
| Control, Hemoglobin | GGM | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Hemoglobin, Automated | GKR | 2 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Whole Blood Hemoglobin Determination | KHG | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 12, 2020 | K200909 | Hemo Control (optional Add Pack Hemo Control DM) | GKR | Substantially Equivalent | Ekf-Diagnostic GmbH | accessdata.fda.gov |
| April 6, 2018 | K172173 | DiaSpect Tm, DiaSpect Tm Cuvettes | GKR | Substantially Equivalent | Ekf-Diagnostic GmbH | accessdata.fda.gov |
| March 4, 2011 | K110393 | EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W | GKR | Substantially Equivalent | Ekf-Diagnostic GmbH | accessdata.fda.gov |
| September 24, 2003 | K031898 | EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM | GKR | Substantially Equivalent | Ekf Diagnostic GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of System, Hemoglobin, Automated
- All makers of Control, Hemoglobin
- All makers of Whole Blood Hemoglobin Determination
- All makers of Calculator/Data Processing Module, For Clinical Use
Updated June 12, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.