測試，成人及兒童尿素（呼吸）
PMA 核准號：P100025 · 2020-05-26
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決定日期2020-05-26
PMA 編號P100025
產品代碼OZA
器械分類3 類
醫療專科M
法規編號21 CFR 8
諮詢委員會MI
(請提供完整的描述文本，以便進行翻譯。)
器材摘要
Test, urea adult and pediatric (breath), is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Bioscience, Inc.. It received FDA 510(k) clearance on 2020-05-26. The device is classified under product code OZA. It was reviewed by the MI advisory panel.
常見問題
What is the Test, urea adult and pediatric (breath),?
Test, urea adult and pediatric (breath), is a medical device that received FDA 510(k) clearance on 2020-05-26. The listed applicant is Meridian Bioscience, Inc..
When did Test, urea adult and pediatric (breath), receive FDA 510(k) clearance?
The clearance date for Test, urea adult and pediatric (breath), can be found in the official FDA records.
Who is the listed applicant for Test, urea adult and pediatric (breath),?
The FDA 510(k) record lists Meridian Bioscience, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Test, urea adult and pediatric (breath),?
The FDA product code for Test, urea adult and pediatric (breath), is OZA.
相關臨床試驗
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官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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