Dropper hsCRP 高灵敏度 CRP 控制剂
K号: K152117 · 2016-04-21
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决定日期2016-04-21
产品代码JJX
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
Dropper hsCRP High Sensitivity CRP Control is the device name listed in this FDA 510(k) record. The listed applicant is Quantimetrix Corporation. It received FDA 510(k) clearance on 2016-04-21 under 510(k) number K152117. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Dropper hsCRP High Sensitivity CRP Control?
Dropper hsCRP High Sensitivity CRP Control is a medical device that received FDA 510(k) clearance on 2016-04-21. The listed applicant is Quantimetrix Corporation. The 510(k) number is K152117.
When did Dropper hsCRP High Sensitivity CRP Control receive FDA 510(k) clearance?
Dropper hsCRP High Sensitivity CRP Control received FDA 510(k) clearance on 2016-04-21, under 510(k) number K152117.
Who is the listed applicant for Dropper hsCRP High Sensitivity CRP Control?
The FDA 510(k) record lists Quantimetrix Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Dropper hsCRP High Sensitivity CRP Control?
The FDA product code for Dropper hsCRP High Sensitivity CRP Control is JJX.
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相关器械（代码：JJX）
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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