Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014506106

FEI Number

3014506106

Entity Name

Radiometer Minneapolis

City/State/Country

New Brighton, MN, US

Establishment Address

121 5th Avenue W, New Brighton, MN 55112, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

RADIOMETER MEDICAL APS (Owner Number: 8020503)

Owner / Operator Contact Address

AAKANDEVEJ 21, --, BROENSHOEJ, DK-84 2700, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K151639

PMA Number

N/A

All Registered Proprietary Names

ABL9 ABL80 CO-OX ABL80 FLEX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2024-12-18
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2022-06-28

Official Correspondent

Hsiao-Qing Chow

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RADIOMETER MEDICAL APS

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9614470	RADIOMETER BASEL AG	BASEL Basel-Stadt, CH
3013513377	Radiometer Solutions Sp. z o.o.	Stargard Zachodniopomorskie, PL
1523456	RADIOMETER AMERICA, INC.	Middleburg Heights, OH, US
3007490412	Radiometer Sp. z o.o	Stargard Zachodniopomorskie, PL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K760969	Instrumentation Laboratory CO	PH/BLOOD GAS SYSTEM	1977-01-12
K820744	Instrumentation Laboratory CO	IL MODEL 1301, PH BLOOD GAS SYSTEM	1982-04-15
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-0038-2008	Radiometer America Inc	2	Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers.
Z-0778-2007	Instrumentation Laboratory Co.	2	GEM Premier 4000 Laboratory Analyzer
Z-0845-03	Instrumentation Laboratory Co.	2	GEM Premier 3000 Pak pH, pC02, pO2, Hct Sensor and Reagent Cartridge. Part No. 24330004 (300 Sample Size) For In-Vitro Diagnostic Use
Z-0846-03	Instrumentation Laboratory Co.	2	GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. Part No. 24345004 (450 Sample Size) For In-Vitro Diagnostic Use
Z-0102-2014	Siemens Healthcare Diagnostics Inc	2	Siemens RAPIDPoint 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014506106. Last updated year: 2026. Please use registration number 3014506106 when referencing this establishment in official correspondence.