FDA applicant

Wyntek Diagnostics, Inc.

San Diego, CA12 decisions1995–20000 recalls

FDA records 12 decisions for Wyntek Diagnostics, Inc. (San Diego, CA) from 1995 to 2000: 12 510(k) clearances. Most are in product codes JHI (Visual, Pregnancy Hcg, Prescription Use) and LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). 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 Wyntek Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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Wyntek Diagnostics, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?