FDA 510(k)

BCR-30-min BI™ and RBIP-ST30™ Readout Accessory

K 號：K151482 · 2016-02-26

決定日期2016-02-26

產品代碼FRC

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

BCR-30-min BI™ and RBIP-ST30™ Readout Accessory is the device name listed in this FDA 510(k) record. The listed applicant is Bcr Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-02-26 under 510(k) number K151482. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BCR-30-min BI™ and RBIP-ST30™ Readout Accessory?

BCR-30-min BI™ and RBIP-ST30™ Readout Accessory is a medical device that received FDA 510(k) clearance on 2016-02-26. The listed applicant is Bcr Diagnostics, Inc.. The 510(k) number is K151482.

When did BCR-30-min BI™ and RBIP-ST30™ Readout Accessory receive FDA 510(k) clearance?

BCR-30-min BI™ and RBIP-ST30™ Readout Accessory received FDA 510(k) clearance on 2016-02-26, under 510(k) number K151482.

Who is the listed applicant for BCR-30-min BI™ and RBIP-ST30™ Readout Accessory?

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

What is the FDA product code for BCR-30-min BI™ and RBIP-ST30™ Readout Accessory?

The FDA product code for BCR-30-min BI™ and RBIP-ST30™ Readout Accessory is FRC.

相關器械（代碼：FRC）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：FRC）

官方來源