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
K903034 SWEDISH TRADE COUNCIL USA RENALYZER PRX 90 03/13/1991


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