FDA applicant

Kronus, Inc.

Star, ID9 decisions1989–20230 recalls

FDA records 9 decisions for Kronus, Inc. (Star, ID) from 1989 to 2023: 8 510(k) clearances and 1 De Novo grant. Most are in product codes JZO (System, Test, Thyroid Autoantibody) and PNI (Aquaporin-4 Autoantibody). No recall is linked to its devices.

FDA’s records also spell it “Kronus”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, immunology panel, where it files most

How often FDA has decided Kronus, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007high 2 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Kronus, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kronus, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Kronus”

FDA records each applicant name separately; these may or may not be the same firm.

Kronus Market Development Associates, Inc. 11

Kronus, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Kronus”