Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Kronus, Inc. with 8 510(k) clearances. The most recent is a 510(k) clearance dated Aug 24, 2023: KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Aug 24, 2023 | KRONUS IA-2 Autoantibody (IA-2Ab) ELISA KitK220085 · OIF | 510(k) clearances |
| Nov 23, 2018 | Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA KitK180607 · PCG | 510(k) clearances |
| Jan 19, 2018 | KRONUS IA-2 Autoantibody (IA-2Ab) ELISA KitK171731 · OIF | 510(k) clearances |
| Jul 22, 2016 | KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA AssayK161951 · PNI | 510(k) clearances |
| Apr 25, 2016 | KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA AssayDEN150030 · PNI | 510(k) clearances |
| Mar 30, 1992 | KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KITK915428 · JZO | 510(k) clearances |
| Mar 30, 1992 | KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KITK915429 · JZO | 510(k) clearances |
| Jul 25, 1989 | ANTI-THYROGLOBULIN TEST KITK894203 · JZO | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
