FDA 510(k)

Aptima BV Assay; Aptima CV/TV Assay

K 號：K243345 · 2024-11-25

決定日期2024-11-25

產品代碼PQA

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

Aptima BV Assay; Aptima CV/TV Assay is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2024-11-25 under 510(k) number K243345. The device is classified under product code PQA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aptima BV Assay; Aptima CV/TV Assay?

Aptima BV Assay; Aptima CV/TV Assay is a medical device that received FDA 510(k) clearance on 2024-11-25. The listed applicant is Hologic, Inc.. The 510(k) number is K243345.

When did Aptima BV Assay; Aptima CV/TV Assay receive FDA 510(k) clearance?

Aptima BV Assay; Aptima CV/TV Assay received FDA 510(k) clearance on 2024-11-25, under 510(k) number K243345.

Who is the listed applicant for Aptima BV Assay; Aptima CV/TV Assay?

FDA 510(k) 記錄將霍洛基克公司（Hologic, Inc.）列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Aptima BV Assay; Aptima CV/TV Assay?

The FDA product code for Aptima BV Assay; Aptima CV/TV Assay is PQA.

其他以 Hologic, Inc. 為申請人之記錄

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相關器械（代碼：PQA）

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

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