SensiTox B. anthracis 毒素測試
K 號：K232545 · 2023-11-20
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器材摘要
The SensiTox B. anthracis Toxin Test is the device name listed in this FDA 510(k) record. The listed applicant is First Light Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-11-20 under 510(k) number K232545. The device is classified under product code QUU. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the The SensiTox B. anthracis Toxin Test?
The SensiTox B. anthracis Toxin Test is a medical device that received FDA 510(k) clearance on 2023-11-20. The listed applicant is First Light Diagnostics, Inc.. The 510(k) number is K232545.
When did The SensiTox B. anthracis Toxin Test receive FDA 510(k) clearance?
The SensiTox B. anthracis Toxin Test received FDA 510(k) clearance on 2023-11-20, under 510(k) number K232545.
Who is the listed applicant for The SensiTox B. anthracis Toxin Test?
The FDA 510(k) record lists First Light Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for The SensiTox B. anthracis Toxin Test?
The FDA product code for The SensiTox B. anthracis Toxin Test is QUU.
相關臨床試驗
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其他以 First Light Diagnostics, Inc. 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。
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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