FDA applicant

Asymmetrx

Amston, CT1 decision2005–20050 recalls

FDA records 1 decision for Asymmetrx (Amston, CT) in 2005: 1 510(k) clearance. All are in product code NTR (Immunohistochemical Reagent, Antibody…). 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Asymmetrx since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Asymmetrx

Which product codes does it file in?

What has FDA decided for it lately?