510(k) Report

FDA applicant

Cronus

Carlsbad, CA3 decisions1986–19870 recalls

FDA records 3 decisions for Cronus (Carlsbad, CA) from 1986 to 1987: 3 510(k) clearances. Most are in product codes JZO (System, Test, Thyroid Autoantibody) and DBL (Multiple Autoantibodies, Indirect…). No recall is linked to its devices.

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 Cronus’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cronus since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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