この記事の翻訳を準備しています。それまでの間、英語の原文を表示します。
ビジネス · 2014/8/251 分で読めます
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of Hemoglobin A1c Test System
ローカル自動翻訳 · 情報源の原言語
概要
The Food and Drug Administration (FDA) is classifying hemoglobin A1c test system into class II (special controls). The special controls that will apply to this device are identified in this order and will be part of the codified language for the hemoglobin A1c test system classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →