510(k) Report

FDA applicant

Cytocolor, Inc.

Hinckley, OH5 decisions1986–19860 recalls

FDA records 5 decisions for Cytocolor, Inc. (Hinckley, OH) in 1986: 5 510(k) clearances. All are in product code LED (Stains, Chemical Solution). 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Cytocolor, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cytocolor, 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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