FDA 510(k) Applications for Medical Device Product Code "CDS"
(Electrode, Ion Specific, Urea Nitrogen)

FDA 510(k) Number Applicant Device Name Decision Date
K033056 DIAMOND DIAGNOSTICS, INC. BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT 01/30/2004
K171247 Epocal Inc. epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test 01/17/2018
K040973 GENCHEM, INC. BUN REAGENT 12/27/2004


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