Albumin BCG2
K号: K203248 · 2021-11-23
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决定日期2021-11-23
产品代码CIX
咨询委员会CH
请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
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器械摘要
Albumin BCG2 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Ireland Diagnostics Division. It received FDA 510(k) clearance on 2021-11-23 under 510(k) number K203248. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Albumin BCG2?
Albumin BCG2 is a medical device that received FDA 510(k) clearance on 2021-11-23. The listed applicant is Abbott Ireland Diagnostics Division. The 510(k) number is K203248.
When did Albumin BCG2 receive FDA 510(k) clearance?
Albumin BCG2 received FDA 510(k) clearance on 2021-11-23, under 510(k) number K203248.
Who is the listed applicant for Albumin BCG2?
The FDA 510(k) record lists Abbott Ireland Diagnostics Division as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Albumin BCG2?
The FDA product code for Albumin BCG2 is CIX.
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列明Abbott Ireland Diagnostics Division为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：CIX）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
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