This page includes the latest FDA filings for Ekf Diagnostic G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3004838836 |
| FEI Number | 3004838836 |
| Name | Stephen Gorski |
| Owner & Operator | EKF DIAGNOSTIC GMBH |
| Contact Address | EBENDORFER CHAUSEE 3 BARLEBEN/MADGEBURG SAXONY-ANHALT DE-NOTA D-39179 DE |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | S65W35739 Piper Rd Eagle, WI 53119 US |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| EKF-diagnostic GmbH | DiaSpect Tm 900-001 | 2022-10-25 |
| EKF-diagnostic GmbH | EKF Link 0760-0101 | 2021-10-25 |
| EKF-diagnostic GmbH | Hemo Control Hemoglobin Microcuvette 3000-3012-0765 | 2021-05-18 |
| EKF-diagnostic GmbH | Hemo Control 3040-0010-0218 | 2021-05-18 |
| EKF-diagnostic GmbH | DiaSpect Control HBT4 900-504 | 2021-03-22 |
| EKF-diagnostic GmbH | DiaSpect Control HBT3 900-503 | 2021-03-22 |
| EKF-diagnostic GmbH | DiaSpect Control HBT2 900-502 | 2021-03-22 |
| EKF-diagnostic GmbH | DiaSpect Control HBT1 900-501 | 2021-03-22 |
| EKF-diagnostic GmbH | DiaSpect Tm Cuvettes 900-500 | 2021-03-19 |
| EKF-diagnostic GmbH | DiaSpect Tm 900-001 | 2021-03-19 |
EKF-diagnostic GmbH | Hemo Control (optional Add Pack Hemo Control DM) | 2020-06-12 |
EKF-diagnostic GmbH | Quo-Test A1c System | 2019-02-16 |
Stephen Gorski [EKF DIAGNOSTIC GMBH] | DiaSpect TM Cuvettes | 2018-04-15 |
Stephen Gorski [EKF DIAGNOSTIC GMBH] | DiaSpect TM Analyzer | 2018-04-15 |
Stephen Gorski [EKF DIAGNOSTIC GMBH] | Consult diagnostics Hemoglobin Cuvettes | 2018-04-15 |
Stephen Gorski [EKF DIAGNOSTIC GMBH] | Consult diagnostics Hemoglobin Analyzer | 2018-04-15 |
Stephen Gorski [EKF DIAGNOSTIC GMBH] | Consult Hb Control Solution Medium Level | 2018-04-15 |
Stephen Gorski [EKF DIAGNOSTIC GMBH] | Consult Hb Control Solution Low Level | 2018-04-15 |
Stephen Gorski [EKF DIAGNOSTIC GMBH] | Consult Hb Control Solution High Level | 2018-04-15 |
EKF-diagnostic GmbH | DiaSpect Tm, DiaSpect Tm Cuvettes | 2018-04-06 |
Stephen Gorski [EKF DIAGNOSTIC GMBH] | Hemo_Control microcuvettes | 2012-01-03 |
Stephen Gorski [EKF DIAGNOSTIC GMBH] | EKF Diagnostic Hemo_Control Hemoglobin Measurement System | 2012-01-03 |
Stephen Gorski [EKF DIAGNOSTIC GMBH] | Hemo_Control microcuvettes | 2012-01-03 |
Stephen Gorski [EKF DIAGNOSTIC GMBH] | EKF Diagnostic Hemo_Control Hemoglobin Measurement System | 2012-01-03 |
EKF-DIAGNOSTIC GMBH | EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W | 2011-03-04 |
Stephen Gorski [EKF DIAGNOSTIC GMBH] | Hemo-Control | 2008-05-12 |
Stephen Gorski [EKF DIAGNOSTIC GMBH] | Hemo-Control | 2008-05-12 |
EKF DIAGNOSTIC GMBH | EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM | 2003-09-24 |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2018030656242 | Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | 5 PACKAGES LOADED ON 3 PALS MULTIFUGE 3 SR B RUNSWICK -80 DEG C FREEZER AKTA FPLC-ANALYSER | 5 PCS |
| 2018030544203 | Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | 5 PACKAGES LOADED ON 3 PALS MULTIFUGE 3 SR B RUNSWICK -80 DEG C FREEZER AKTA FPLC-ANALYSER | 5 PCS |