炭疽芽孢桿菌實時PCR試劑
K 號：K192871 · 2019-11-07
廣告
決定日期2019-11-07
產品代碼NHT
諮詢委員會MI
(請提供完整的描述文本，以便進行翻譯。)
決定相當於
器材摘要
B. anthracis Real-time PCR Assay is the device name listed in this FDA 510(k) record. The listed applicant is Centers for Disease Control and Prevention. It received FDA 510(k) clearance on 2019-11-07 under 510(k) number K192871. The device is classified under product code NHT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the B. anthracis Real-time PCR Assay?
B. anthracis Real-time PCR Assay is a medical device that received FDA 510(k) clearance on 2019-11-07. The listed applicant is Centers for Disease Control and Prevention. The 510(k) number is K192871.
When did B. anthracis Real-time PCR Assay receive FDA 510(k) clearance?
B. anthracis Real-time PCR Assay received FDA 510(k) clearance on 2019-11-07, under 510(k) number K192871.
Who is the listed applicant for B. anthracis Real-time PCR Assay?
The FDA 510(k) record lists Centers for Disease Control and Prevention as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for B. anthracis Real-time PCR Assay?
The FDA product code for B. anthracis Real-time PCR Assay is NHT.
相關臨床試驗
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其他以 Centers for Disease Control and Prevention 為申請人之記錄
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
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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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