FDA applicant

Orgentec

Windham, NH10 decisions1995–19960 recalls

FDA records 10 decisions for Orgentec (Windham, NH) from 1995 to 1996: 10 510(k) clearances. Most are in product codes LJM (Antinuclear Antibody (Enzyme-Labeled)…) and LLL (Extractable Antinuclear Antibody, Antigen And…). 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, immunology panel, where it files most

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

FDA decisions per year

No FDA decision for Orgentec since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Orgentec’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Orgentec”

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

Orgentec Diagnostika GmbH 3

Orgentec

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Orgentec”