510(k) Report

FDA applicant

Cyberfluor, Inc.

Ontario M5t 1x4, CA17 decisions1987–19920 recalls

FDA records 17 decisions for Cyberfluor, Inc. (Ontario M5t 1x4, CA) from 1987 to 1992: 17 510(k) clearances. Most are in product codes CEP (Radioimmunoassay, Luteinizing Hormone) and JLW (Radioimmunoassay, Thyroid-Stimulating Hormone). 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 Cyberfluor, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cyberfluor, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cyberfluor, Inc.’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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