FDA 510(k)

CareStart 流感A&B Plus

K 號：K191514 · 2020-02-18

決定日期2020-02-18

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

CareStart Flu A&B Plus is the device name listed in this FDA 510(k) record. The listed applicant is Access Bio, Inc.. It received FDA 510(k) clearance on 2020-02-18 under 510(k) number K191514. 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 CareStart Flu A&B Plus?

CareStart Flu A&B Plus is a medical device that received FDA 510(k) clearance on 2020-02-18. The listed applicant is Access Bio, Inc.. The 510(k) number is K191514.

When did CareStart Flu A&B Plus receive FDA 510(k) clearance?

CareStart Flu A&B Plus received FDA 510(k) clearance on 2020-02-18, under 510(k) number K191514.

Who is the listed applicant for CareStart Flu A&B Plus?

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

What is the FDA product code for CareStart Flu A&B Plus?

The FDA product code for CareStart Flu A&B Plus is PSZ.

其他以 Access Bio, 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。

K251604CareSuperb COVID-19/流感A&B抗原組合居家檢測 K241915CareSuperb™ COVID-19 抗原家庭檢測

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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官方來源

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