FDA 510(k)

ST AIA-PACK hsE2 校準器組

K 號：K160113 · 2016-02-17

決定日期2016-02-17

產品代碼JIT

諮詢委員會CH

決定相當於

器材摘要

ST AIA-PACK hsE2 Calibrator Set is the device name listed in this FDA 510(k) record. The listed applicant is Tosoh Bioscience, Inc.. It received FDA 510(k) clearance on 2016-02-17 under 510(k) number K160113. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ST AIA-PACK hsE2 Calibrator Set?

ST AIA-PACK hsE2 Calibrator Set is a medical device that received FDA 510(k) clearance on 2016-02-17. The listed applicant is Tosoh Bioscience, Inc.. The 510(k) number is K160113.

When did ST AIA-PACK hsE2 Calibrator Set receive FDA 510(k) clearance?

ST AIA-PACK hsE2 Calibrator Set received FDA 510(k) clearance on 2016-02-17, under 510(k) number K160113.

Who is the listed applicant for ST AIA-PACK hsE2 Calibrator Set?

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

What is the FDA product code for ST AIA-PACK hsE2 Calibrator Set?

The FDA product code for ST AIA-PACK hsE2 Calibrator Set is JIT.

其他以 Tosoh Bioscience, Inc. 為申請人之記錄

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相關器械（代碼：JIT）

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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