QNext和DG-PT
K号: K183390 · 2019-08-21
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决定日期2019-08-21
产品代码JPA
咨询委员会HE
请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
QNext and DG-PT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Grifols, S.A.. It received FDA 510(k) clearance on 2019-08-21 under 510(k) number K183390. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the QNext and DG-PT?
QNext and DG-PT is a medical device that received FDA 510(k) clearance on 2019-08-21. The listed applicant is Diagnostic Grifols, S.A.. The 510(k) number is K183390.
When did QNext and DG-PT receive FDA 510(k) clearance?
QNext and DG-PT received FDA 510(k) clearance on 2019-08-21, under 510(k) number K183390.
Who is the listed applicant for QNext and DG-PT?
The FDA 510(k) record lists Diagnostic Grifols, S.A. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for QNext and DG-PT?
The FDA product code for QNext and DG-PT is JPA.
相关临床试验
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：JPA）
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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