510(k) Report

FDA applicant

Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM

Vienna, AT1 decision2024–20240 recalls

FDA records 1 decision for Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM (Vienna, AT) in 2024: 1 De Novo grant. All are in product code SAC (Adamts13 Activity Test System). 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 Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024: 1
2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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