Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004838836

FEI Number

3004838836

Entity Name

EKF DIAGNOSTIC GMBH

City/State/Country

BARLEBEN/MADGEBURG Saxony-Anhalt, DE

Establishment Address

EBENDORFER CHAUSEE 3, BARLEBEN/MADGEBURG Saxony-Anhalt D-39179, DE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

EKF DIAGNOSTIC GMBH (Owner Number: 9057009)

Owner / Operator Contact Address

EBENDORFER CHAUSEE 3, BARLEBEN/MADGEBURG, SAXONY-ANHALT, DE-NOTA D-39179, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK200520

PMA Number

N/A

All Registered Proprietary Names

EKF Link EKF Diagnostic Hemo_Control Hemoglobin Measurement System Hemo_Control microcuvettes Consult Hb Control Solution High Level DiaSpect TM Analyzer DiaSpect TM Cuvettes Consult Hb Control Solution Medium Level Consult Hb Control Solution Low Level Consult diagnostics Hemoglobin Analyzer Consult diagnostics Hemoglobin Cuvettes Hemo-Control Hemo Control DiaSpect Control Pack HBT4 (90B014) DiaSpect Control Pack HBT3 (90B013) DiaSpect Control Pack HBT2 (90B012) DiaSpect Control HBT1 DiaSpect Control HBT2 DiaSpect Control HBT3 DiaSpect Control HBT4 DiaSpect Tm Cuvettes DiaSpect Tm

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2021-10-14
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2012-01-03
KHG	Whole Blood Hemoglobin Determination	Hematology	Class 2	864.7500	2012-01-03
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2018-04-15
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2008-05-12
KHG	Whole Blood Hemoglobin Determination	Hematology	Class 2	864.7500	2008-05-12
KHG	Whole Blood Hemoglobin Determination	Hematology	Class 2	864.7500	2023-08-14
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2023-08-14
GGM	Control, Hemoglobin	Hematology	Class 2	864.8625	2022-12-16
GGM	Control, Hemoglobin	Hematology	Class 2	864.8625	2021-03-09
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2021-03-09

Official Correspondent

No official correspondent registered.

US Agent Details

Stephen Gorski Business: Imagenix, Inc. Email: stephengorski@me.com Phone: (414) 7374596

Related Public Records

Same Entity

EKF DIAGNOSTIC GMBH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K781173	Instrumentation Laboratory CO	COMPUTER INTERFACE IL 814	1978-09-14
K760208	Instrumentation Laboratory CO	OXIMETER, CO-, IL MODEL 282	1976-07-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-04	Misys Healthcare Systems	1	Calculator/Data Processing Module for Clinical Use
Z-0026-2025	Becton Dickinson & Co.	1	BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150

Similar Registrations

Registration Number	Establishment Name	Location
3004032053	Abbott S.r.l.	Milan Lombardy, IT
3013922172	INDIGO BIOAUTOMATION, INC.	Carmel, IN, US
3012436569	NATIONAL TECHNOLOGY FOR SOFTWARE	Cairo Al Qahirah, EG
3015426626	Aclarion, Inc.	Broomfield, CO, US
3030413550	LIFE DATA LAB, LLC	New York, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004838836. Last updated year: 2026. Please use registration number 3004838836 when referencing this establishment in official correspondence.