FDA 510(k)

BCR-30-min BI® 和 RBIP-ST30® 读出附件

K号: K151482 · 2016-02-26

决定日期2016-02-26

产品代码FRC

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

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.

常见问题

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.

相关器械（代码：FRC）

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

器械摘要

常见问题

相关临床试验

相关器械（代码：FRC）

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