510(k) Report

FDA applicant

N-Dia, Inc.

New York, NY1 decision2004–20041 recall

FDA records 1 decision for N-Dia, Inc. (New York, NY) in 2004: 1 510(k) clearance. All are in product code JJX (Single (Specified) Analyte Controls (Assayed…). 1 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 chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for N-Dia, Inc. since 2007.

Recalls per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K030849Amnisure Fetal Membranes Rupture Test Model FMRT1N-Dia, Inc. · 20042cite it

What has FDA decided for it lately?

  • K030849Amnisure Fetal Membranes Rupture Test Model FMRT1N-Dia, Inc. · 20041 recall

The one decision as N-Dia, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K030849AmniSure ROM Test, Fetal Membrane Rupture Test for In-Vitro Diagnostic Use, Model…Oct 3, 2007