510(k) Report

FDA applicant

Visual Diagnostics, Inc.

Teaneck, NJ1 decision1986–19860 recalls

FDA records 1 decision for Visual Diagnostics, Inc. (Teaneck, NJ) in 1986: 1 510(k) clearance. All are in product code DHB (System, Test, Radioallergosorbent (Rast)…). 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 Visual Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Visual Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Visual Diagnostics, 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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Other applicant names beginning “Visual”

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