FDA 510(k)

XSTAT-12，3入包，XSTAT-12，1入包

K 號：K161020 · 2016-07-28

決定日期2016-07-28

產品代碼PGZ

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

XSTAT-12, 3-Pack, XSTAT-12, 1-Pack is the device name listed in this FDA 510(k) record. The listed applicant is Revmedx, Inc.. It received FDA 510(k) clearance on 2016-07-28 under 510(k) number K161020. The device is classified under product code PGZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the XSTAT-12, 3-Pack, XSTAT-12, 1-Pack?

XSTAT-12, 3-Pack, XSTAT-12, 1-Pack is a medical device that received FDA 510(k) clearance on 2016-07-28. The listed applicant is Revmedx, Inc.. The 510(k) number is K161020.

When did XSTAT-12, 3-Pack, XSTAT-12, 1-Pack receive FDA 510(k) clearance?

XSTAT-12, 3-Pack, XSTAT-12, 1-Pack received FDA 510(k) clearance on 2016-07-28, under 510(k) number K161020.

Who is the listed applicant for XSTAT-12, 3-Pack, XSTAT-12, 1-Pack?

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

What is the FDA product code for XSTAT-12, 3-Pack, XSTAT-12, 1-Pack?

The FDA product code for XSTAT-12, 3-Pack, XSTAT-12, 1-Pack is PGZ.

其他以 Revmedx, 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。

K253290XSTAT P15 K210676XSTAT 30 袋 K180051XSTAT 30, 1入包 K170334XSTAT 30，3入包；XSTAT 30，1入包；XSTAT 12，3包；XSTAT 12，1包

相關器械（代碼：PGZ）

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。

K253290XSTAT P15Revmedx, Inc.K210676XSTAT 30 袋Revmedx, Inc.K180051XSTAT 30, 1入包Revmedx, Inc.K170334XSTAT 30，3入包；XSTAT 30，1入包；XSTAT 12，3包；XSTAT 12，1包Revmedx, Inc.

官方來源

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