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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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