510(k) Report

FDA applicant

Diagnostics Direct, LLC

East Stroudsburg, PA1 decision2011–20110 recalls

FDA records 1 decision for Diagnostics Direct, LLC (East Stroudsburg, PA) in 2011: 1 510(k) clearance. All are in product code LIP (Enzyme Linked Immunoabsorption Assay…). Its devices cite 1 predicate, 0 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 Diagnostics Direct, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Diagnostics Direct, LLC by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LIPEnzyme Linked Immunoabsorption Assay, Treponema Pallidum1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K102400Syphilis Health CheckDiagnostics Direct, LLC · 2011

The one decision as Diagnostics Direct, LLC →