FDA 510(k)

弗朗西斯菌屬實時PCR檢測試劑

K 號：K260812 · 2026-03-30

申請人Centers for Disease Control and Prevention

決定日期2026-03-30

產品代碼SGA

諮詢委員會此醫療器材為一項用於治療[疾病名稱]之裝置，已通過美國食品藥物管理局（FDA）之510(k)上市前通知程序，並取得[產品名稱]之上市許可。本裝置亦已獲得PMA（上市前核准）之認可，相關臨床試驗資料已登錄於ClinicalTrials.gov（NCT編號：[NCT號碼]），並已發表於經同儕審查之醫學期刊（PMID：[PMID號碼]）。更多詳細資訊請參閱：[URL]。

決定相當於

器材摘要

Francisella tularensis 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 2026-03-30 under 510(k) number K260812. The device is classified under product code SGA. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Francisella tularensis Real-time PCR Assay?

Francisella tularensis Real-time PCR Assay is a medical device that received FDA 510(k) clearance on 2026-03-30. The listed applicant is Centers for Disease Control and Prevention. The 510(k) number is K260812.

When did Francisella tularensis Real-time PCR Assay receive FDA 510(k) clearance?

Francisella tularensis Real-time PCR Assay received FDA 510(k) clearance on 2026-03-30, under 510(k) number K260812.

Who is the listed applicant for Francisella tularensis 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 Francisella tularensis Real-time PCR Assay?

The FDA product code for Francisella tularensis Real-time PCR Assay is SGA.

其他以 Centers for Disease Control and Prevention 為申請人之記錄

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相關器械（代碼：SGA）

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。

K252072弗朗西斯菌屬實時PCR檢測試劑Centers for Disease Control and Prevention

官方來源

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