FDA 510(k)

生物信流感A+B

K 號：K182157 · 2018-09-18

決定日期2018-09-18

產品代碼PSZ

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

BioSign Flu A+B is the device name listed in this FDA 510(k) record. The listed applicant is Princeton BioMeditech Corp.. It received FDA 510(k) clearance on 2018-09-18 under 510(k) number K182157. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BioSign Flu A+B?

BioSign Flu A+B is a medical device that received FDA 510(k) clearance on 2018-09-18. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K182157.

When did BioSign Flu A+B receive FDA 510(k) clearance?

BioSign Flu A+B received FDA 510(k) clearance on 2018-09-18, under 510(k) number K182157.

Who is the listed applicant for BioSign Flu A+B?

The FDA 510(k) record lists Princeton BioMeditech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioSign Flu A+B?

The FDA product code for BioSign Flu A+B is PSZ.

其他以 Princeton BioMeditech Corp. 為申請人之記錄

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K251538Status™ COVID-19/流感A&B

相關器械（代碼：PSZ）

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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