Ekf Diagnostic G M B H

FDA Filings

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.

FDA Registration(s)
Registration Number3004838836
FEI Number3004838836
NameStephen Gorski
Owner & OperatorEKF DIAGNOSTIC GMBH
Contact AddressEBENDORFER CHAUSEE 3 BARLEBEN/MADGEBURG
SAXONY-ANHALT DE-NOTA D-39179 DE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressS65W35739 Piper Rd
Eagle, WI 53119 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
EKF-diagnostic GmbH
Hemo Control (optional Add Pack Hemo Control DM)2020-06-12
EKF-diagnostic GmbH
Quo-Test A1c System2019-02-16
Stephen Gorski [EKF DIAGNOSTIC GMBH]
DiaSpect TM Cuvettes2018-04-15
Stephen Gorski [EKF DIAGNOSTIC GMBH]
DiaSpect TM Analyzer2018-04-15
Stephen Gorski [EKF DIAGNOSTIC GMBH]
Consult diagnostics Hemoglobin Cuvettes2018-04-15
Stephen Gorski [EKF DIAGNOSTIC GMBH]
Consult diagnostics Hemoglobin Analyzer2018-04-15
Stephen Gorski [EKF DIAGNOSTIC GMBH]
Consult Hb Control Solution Medium Level2018-04-15
Stephen Gorski [EKF DIAGNOSTIC GMBH]
Consult Hb Control Solution Low Level2018-04-15
Stephen Gorski [EKF DIAGNOSTIC GMBH]
Consult Hb Control Solution High Level2018-04-15
EKF-diagnostic GmbH
DiaSpect Tm, DiaSpect Tm Cuvettes2018-04-06
Stephen Gorski [EKF DIAGNOSTIC GMBH]
Hemo_Control microcuvettes2012-01-03
Stephen Gorski [EKF DIAGNOSTIC GMBH]
EKF Diagnostic Hemo_Control Hemoglobin Measurement System2012-01-03
Stephen Gorski [EKF DIAGNOSTIC GMBH]
Hemo_Control microcuvettes2012-01-03
Stephen Gorski [EKF DIAGNOSTIC GMBH]
EKF Diagnostic Hemo_Control Hemoglobin Measurement System2012-01-03
EKF-DIAGNOSTIC GMBH
EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W2011-03-04
Stephen Gorski [EKF DIAGNOSTIC GMBH]
Hemo-Control2008-05-12
Stephen Gorski [EKF DIAGNOSTIC GMBH]
Hemo-Control2008-05-12
EKF DIAGNOSTIC GMBH
EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM2003-09-24

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