Distinct®數位懷孕檢測器
K 號：K232715 · 2024-05-31
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器材摘要
Distinct® Digital Pregnancy Test is the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2024-05-31 under 510(k) number K232715. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Distinct® Digital Pregnancy Test?
Distinct® Digital Pregnancy Test is a medical device that received FDA 510(k) clearance on 2024-05-31. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K232715.
When did Distinct® Digital Pregnancy Test receive FDA 510(k) clearance?
Distinct® Digital Pregnancy Test received FDA 510(k) clearance on 2024-05-31, under 510(k) number K232715.
Who is the listed applicant for Distinct® Digital Pregnancy Test?
The FDA 510(k) record lists ACON Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Distinct® Digital Pregnancy Test?
The FDA product code for Distinct® Digital Pregnancy Test is LCX.
相關臨床試驗
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其他以 ACON Laboratories, 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。
相關器械（代碼：LCX）
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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