FDA 510(k)

Cepheid Xpert SA 鼻腔完整控制面板

K 號：K191168 · 2019-06-25

決定日期2019-06-25

產品代碼PMN

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

Cepheid Xpert SA Nasal Complete Control Panel is the device name listed in this FDA 510(k) record. The listed applicant is Microbiologics, Inc.. It received FDA 510(k) clearance on 2019-06-25 under 510(k) number K191168. The device is classified under product code PMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cepheid Xpert SA Nasal Complete Control Panel?

Cepheid Xpert SA Nasal Complete Control Panel is a medical device that received FDA 510(k) clearance on 2019-06-25. The listed applicant is Microbiologics, Inc.. The 510(k) number is K191168.

When did Cepheid Xpert SA Nasal Complete Control Panel receive FDA 510(k) clearance?

Cepheid Xpert SA Nasal Complete Control Panel received FDA 510(k) clearance on 2019-06-25, under 510(k) number K191168.

Who is the listed applicant for Cepheid Xpert SA Nasal Complete Control Panel?

The FDA 510(k) record lists Microbiologics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cepheid Xpert SA Nasal Complete Control Panel?

The FDA product code for Cepheid Xpert SA Nasal Complete Control Panel is PMN.

其他以 Microbiologics, Inc. 為申請人之記錄

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相關器械（代碼：PMN）

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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