FDA applicant

Nano-Ditech Corporation

Cranbury, NJ8 decisions2005–20260 recalls

FDA records 8 decisions for Nano-Ditech Corporation (Cranbury, NJ) from 2005 to 2026: 8 510(k) clearances. Most are in product codes MMI (Immunoassay Method, Troponin Subunit) and SCA (Multi-Analyte Respiratory Virus Antigen…). Its devices cite 9 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Nano-Ditech Co.”.

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 Nano-Ditech Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007high 2 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Nano-Ditech Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Nano-Ditech Corporation

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?