510(k) Report

FDA applicant

Cetus Corp.

Emeryville, CA3 decisions1983–19860 recalls

FDA records 3 decisions for Cetus Corp. (Emeryville, CA) from 1983 to 1986: 3 510(k) clearances. Most are in product codes LJO (Antigen, Iha, Cytomegalovirus) and JFH (Acid Phosphatase (Prostatic), Tartrate Inhibited). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Cetus Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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