510(k) Report

FDA applicant

Cd Diagnostics, Inc.

Claymont, DE2 decisions2019–20210 recalls

FDA records 2 decisions for Cd Diagnostics, Inc. (Claymont, DE) from 2019 to 2021: 1 510(k) clearance and 1 De Novo grant. All are in product code QGN (Lateral Flow Immunochromatography Assay For…). Its devices cite 1 predicate, 1 of them its own earlier devices. 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, microbiology panel, where it files most

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

FDA decisions per year

1in 2021

2019: 12021: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Cd Diagnostics, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cd 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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Which product codes does it file in?

  • QGNLateral Flow Immunochromatography Assay For Host Infection Biomarkers2decisions

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN180032Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test)…Cd Diagnostics, Inc. · 20192cite it

What has FDA decided for it lately?

  • K212204Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5…Cd Diagnostics, Inc. · 2021
  • DEN180032Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test)…Cd Diagnostics, Inc. · 2019

All 2 as Cd Diagnostics, Inc. →