FDA 510(k) Applications for Medical Device Product Code: CGL (Electrode, Ion Based, Enzymatic, Creatinine)

FDA 510(k) Applications for Medical Device Product Code "CGL"
(Electrode, Ion Based, Enzymatic, Creatinine)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K113726	EPOCAL, INC.	EPOC CHLORIDE TEST AND EPOC CREATININE TEST	10/05/2012
K973292	I-STAT CORP.	I-STAT SYSTEM	10/20/1997
K070068	NOVA BIOMEDICAL CORP.	NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS	05/07/2007
K991727	NOVA BIOMEDICAL CORP.	STAT PROFILE M7 ANALYZER	07/16/1999
K171059	Nova Biomedical Corporation	Nova StatSensor Creatinine Hospital Meter System	05/26/2017
K051968	RADIOMETER MEDICAL APS	ABL8X7 FLEX	10/16/2006