簡易-COLLECT 性傳染病檢測
K 號：K243410 · 2025-01-30
廣告
器材摘要
simpli-COLLECT STI Test is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Molecular. It received FDA 510(k) clearance on 2025-01-30 under 510(k) number K243410. The device is classified under product code QYA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the simpli-COLLECT STI Test?
simpli-COLLECT STI Test is a medical device that received FDA 510(k) clearance on 2025-01-30. The listed applicant is Abbott Molecular. The 510(k) number is K243410.
When did simpli-COLLECT STI Test receive FDA 510(k) clearance?
simpli-COLLECT STI Test received FDA 510(k) clearance on 2025-01-30, under 510(k) number K243410.
Who is the listed applicant for simpli-COLLECT STI Test?
The FDA 510(k) record lists Abbott Molecular as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for simpli-COLLECT STI Test?
The FDA product code for simpli-COLLECT STI Test is QYA.
相關臨床試驗
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。
其他以 Abbott Molecular 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。
廣告