Kronus, Inc.

FDA Regulatory Profile

Kronus, Inc. appears in FDA public data with 0 recalls, 9 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on August 24, 2023.

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
K915428KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KITMarch 30, 1992
K915429KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KITMarch 30, 1992
K894203ANTI-THYROGLOBULIN TEST KITJuly 25, 1989
K894364MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)July 25, 1989