510(k) Report

FDA applicant

Alidex, Inc.

Redmond, WA2 decisions2002–20030 recalls

FDA records 2 decisions for Alidex, Inc. (Redmond, WA) from 2002 to 2003: 2 510(k) clearances. All are in product code JHI (Visual, Pregnancy Hcg, Prescription Use). 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 Alidex, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Alidex, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Alidex, 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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