Data / Medical devices / Poland / Radiometer Solutions Sp. z o.o.

Radiometer Solutions Sp. z o.o.: FDA-registered device maker in Stargard Zachodniopomorskie, Poland, 4 510(k) clearances

Name: Radiometer Solutions Sp. z o.o. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Radiometer Solutions Sp. z o.o. is registered with the FDA (registration 3013513377) in Stargard Zachodniopomorskie, Poland. It lists 25 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 13, 2015. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013513377
Address: Stalowa 6, Stargard Zachodniopomorskie, Poland, 73-110
Owner or operator: RADIOMETER MEDICAL APS (8020503)
Roles: Complaint file establishment, Contract manufacturer
First device listed: March 25, 2015
Registered through: 2026
Brand names listed: 905-802 D513 Disposable Waste Container, 909-590 D512 Disposable waste container, 944-057 S4970 Rinse Solution, 944-064 S1720 Calibration Solution 1, 944-074 S7735 AutoCheck5+ Level 1, 944-075 S7745 AutoCheck 5+ Level 2, 944-076 S7755 AutoCheck 5+ Level 3, 944-077 S7765 AutoCheck5+ Level 4 and more

Devices it lists

Device	Product code	Class	Role	Source
Acid, Lactic, Enzymatic Method	KHP	1	Contract manufacturer	accessdata.fda.gov
Assay, Carboxyhemoglobin	GHS	2	Contract manufacturer	accessdata.fda.gov
Assay, Fetal Hemoglobin	KQI	2	Contract manufacturer	accessdata.fda.gov
Bilirubin (Total And Unbound) In The Neonate Test System	MQM	1	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Calibrator, Multi-Analyte Mixture	JIX	2	Contract manufacturer	accessdata.fda.gov
Controls For Blood-Gases, (Assayed And Unassayed)	JJS	1	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Device, Hematocrit Measuring	JPI	2	Contract manufacturer	accessdata.fda.gov
Diazo Colorimetry, Bilirubin	CIG	2	Contract manufacturer	accessdata.fda.gov
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	CHL	2	Contract manufacturer	accessdata.fda.gov
Electrode, Ion Based, Enzymatic, Creatinine	CGL	2	Contract manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Calcium	JFP	2	Contract manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Potassium	CEM	2	Contract manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Sodium	JGS	2	Contract manufacturer	accessdata.fda.gov
Electrode, Ion-Specific, Chloride	CGZ	2	Contract manufacturer	accessdata.fda.gov
Glucose Oxidase, Glucose	CGA	2	Contract manufacturer	accessdata.fda.gov
Instrument, Hematocrit, Automated	GKF	2	Contract manufacturer	accessdata.fda.gov
Monitor, Carbon-Dioxide, Cutaneous	LKD	2	Contract manufacturer	accessdata.fda.gov
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	KLK	2	Contract manufacturer	accessdata.fda.gov
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia	LPP	2	Contract manufacturer	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Contract manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Contract manufacturer	accessdata.fda.gov
Oximeter, Ear	DPZ	2	Contract manufacturer	accessdata.fda.gov
Syringe, Antistick	MEG	2	Contract manufacturer	accessdata.fda.gov
System, Hemoglobin, Automated	GKR	2	Contract manufacturer	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 13, 2015	K150226	Hematocrit and Metabolite QUALICHECK	JJS	Substantially Equivalent	Radiometer Medical Aps	accessdata.fda.gov
November 13, 2014	K132691	ABL90 FLEX	MQM	Substantially Equivalent	Radiometer Medical Aps	accessdata.fda.gov
March 26, 2013	K130415	HIGH METABOLITE QUALICHECK	JJS	Substantially Equivalent	Radiometer Medical Aps	accessdata.fda.gov
March 15, 2013	K130236	RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3	JJS	Substantially Equivalent	Radiometer Medical Aps	accessdata.fda.gov

Compare with other makers

Updated May 13, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.