FDA 510(k) Applications for Medical Device Product Code "PNI"

FDA 510(k) Number Applicant Device Name Decision Date
DEN150030 KRONUS, INC. KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay 04/25/2016
K161951 KRONUS, INC. KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay 07/22/2016


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