510(k) Report

FDA applicant

Genua 1944, Inc.

Blairstown, NJ1 decision2001–20010 recalls

FDA records 1 decision for Genua 1944, Inc. (Blairstown, NJ) in 2001: 1 510(k) clearance. All are in product code CGJ (Radioimmunoassay, Follicle-Stimulating Hormone). 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, clinical chemistry panel, where it files most

How often FDA has decided Genua 1944, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Genua 1944, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Genua 1944, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Genua 1944, 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?

  • CGJRadioimmunoassay, Follicle-Stimulating Hormone1decision

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.

  • K002450Genua Menopause Monitor Test KitGenua 1944, Inc. · 20011cites it

What has FDA decided for it lately?

  • K002450Genua Menopause Monitor Test KitGenua 1944, Inc. · 2001

The one decision as Genua 1944, Inc. →