Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003044483

FEI Number

3003044483

Entity Name

HEMOCUE AB

City/State/Country

ANGELHOLM Skane, SE

Establishment Address

KUVETTGATAN 1, ANGELHOLM Skane SE-262 71, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HemoCue AB (Owner Number: 9099323)

Owner / Operator Contact Address

Kuvettgatan 1, Angelholm, SE-M 26271, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK000043

PMA Number

N/A

All Registered Proprietary Names

HemoCue Hb 301 System HemoCue Glucose 201 System HemoCue WBC System HemoCue Hb 201 DM System HemoCue Hb 801 System HemoCue Hb 301 System HemoCue Plasma/Low System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2007-11-09
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2007-11-09
GKL	Counter, Cell, Automated (Particle Counter)	Hematology	Class 2	864.5200	2007-11-09
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2007-11-09
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2019-02-04
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2020-08-18
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2007-11-09

Official Correspondent

Andrijana Kankaras

US Agent Details

Matt Ackerman Business: Radiometer America Inc. Email: mackerman@radiometeramerica.com Phone: (657) 2861022

Related Public Records

Same Entity

HemoCue AB

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
K811074	Reagents Applications, Inc.	GLUCOSE REAGENT-ENZYMATIC-COLOR 500	1981-04-29
K936212	Heraeus Kulzer, Inc.	GLUCOFILM TEST STRIPS	1994-05-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0378-06	Instrumentation Laboratory Co.	2	GEM PREMIER 3000
Z-2165-2011	Instrumentation Laboratory Co.	2	Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-OXimetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acidlbase status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus

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3005146144	UAB KITRON	KAUNAS Kauno Apskritis, LT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003044483. Last updated year: 2026. Please use registration number 3003044483 when referencing this establishment in official correspondence.