Clearblue® 早期妊娠测试
K号: K213379 · 2022-09-21
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决定日期2022-09-21
产品代码LCX
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
Clearblue ® Early Pregnancy Test is the device name listed in this FDA 510(k) record. The listed applicant is Spd Swiss Precision Diagnostics GmbH. It received FDA 510(k) clearance on 2022-09-21 under 510(k) number K213379. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Clearblue ® Early Pregnancy Test?
Clearblue ® Early Pregnancy Test is a medical device that received FDA 510(k) clearance on 2022-09-21. The listed applicant is Spd Swiss Precision Diagnostics GmbH. The 510(k) number is K213379.
When did Clearblue ® Early Pregnancy Test receive FDA 510(k) clearance?
Clearblue ® Early Pregnancy Test received FDA 510(k) clearance on 2022-09-21, under 510(k) number K213379.
Who is the listed applicant for Clearblue ® Early Pregnancy Test?
The FDA 510(k) record lists Spd Swiss Precision Diagnostics GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Clearblue ® Early Pregnancy Test?
The FDA product code for Clearblue ® Early Pregnancy Test is LCX.
相关临床试验
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列明Spd Swiss Precision Diagnostics GmbH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：LCX）
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
在 FDA 数据库中查看 →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。
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