Kronus

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K220085KRONUS IA-2 Autoantibody (IA-2Ab) ELISA KitAugust 24, 2023
K180607Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA KitNovember 23, 2018
K171731KRONUS IA-2 Autoantibody (IA-2Ab) ELISA KitJanuary 19, 2018
K161951KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA AssayJuly 22, 2016
DEN150030KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA AssayApril 25, 2016
K915429KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KITMarch 30, 1992
K915428KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KITMarch 30, 1992
K894364MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)July 25, 1989
K894203ANTI-THYROGLOBULIN TEST KITJuly 25, 1989