Company ยท US
Kronus, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2023. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 24, 2023 | K220085 | KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit Kronus, Inc. | OIF |
| Nov 23, 2018 | K180607 | Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit Kronus, Inc. | PCG |
| Jan 19, 2018 | K171731 | KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit Kronus, Inc. | OIF |
| Jul 22, 2016 | K161951 | KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay Kronus, Inc. | PNI |
| Apr 25, 2016 | DEN150030 | KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay Kronus, Inc. | PNI |
| Mar 30, 1992 | K915429 | KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KIT Kronus | JZO |
| Mar 30, 1992 | K915428 | KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT Kronus | JZO |
| Jul 25, 1989 | K894364 | MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) Kronus | JZO |
| Jul 25, 1989 | K894203 | ANTI-THYROGLOBULIN TEST KIT Kronus | JZO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||