510(k) Report

FDA applicant

Polymedco Cancer Diagnostics, LLC

Cortlandt Manor, NY1 decision2010–20100 recalls

FDA records 1 decision for Polymedco Cancer Diagnostics, LLC (Cortlandt Manor, NY) in 2010: 1 510(k) clearance. All are in product code OOX (Automated Occult Blood Analyzer). 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, hematology panel, where it files most

How often FDA has decided Polymedco Cancer Diagnostics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Polymedco Cancer Diagnostics, LLC by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OOXAutomated Occult Blood Analyzer1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K092330OC-Sensor Diana Ifob TestPolymedco Cancer Diagnostics, LLC · 20101cites it

What has FDA decided for it lately?

  • K092330OC-Sensor Diana Ifob TestPolymedco Cancer Diagnostics, LLC · 2010

The one decision as Polymedco Cancer Diagnostics, LLC →

Other applicant names beginning “Polymedco”

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

Polymedco, Inc. 19