510(k) Report

FDA applicant

Procisedx, Inc.

San Diego, CA2 decisions2023–20230 recalls

FDA records 2 decisions for Procisedx, Inc. (San Diego, CA) in 2023: 2 De Novo grants. Most are in product codes QYD (Adalimumab Assay) and QXT (Infliximab Test System). 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 toxicology panel, where it files most

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

FDA decisions per year

2in 2023

2023: 2
2023high 2 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Procisedx, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QYDAdalimumab Assay1decision
  • QXTInfliximab Test System1decision

What has FDA decided for it lately?

All 2 as Procisedx, Inc. →