INNOVANCE Free PS Ag
K号: K181525 · 2018-09-07
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决定日期2018-09-07
产品代码GGP
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
INNOVANCE Free PS Ag is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2018-09-07 under 510(k) number K181525. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the INNOVANCE Free PS Ag?
INNOVANCE Free PS Ag is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K181525.
When did INNOVANCE Free PS Ag receive FDA 510(k) clearance?
INNOVANCE Free PS Ag received FDA 510(k) clearance on 2018-09-07, under 510(k) number K181525.
Who is the listed applicant for INNOVANCE Free PS Ag?
The FDA 510(k) record lists Siemens Healthcare Diagnostics Products GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for INNOVANCE Free PS Ag?
The FDA product code for INNOVANCE Free PS Ag is GGP.
相关临床试验
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列明Siemens Healthcare Diagnostics Products 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：GGP）
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。
K251440CRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc.K230852HemosIL显色因子IXInstrumentation Laboratory CompanyK220728vWF抗原Siemens Healthcare Diagnostics Products GmbHK214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc.K223402HemosIL von Willebrand 因子抗原Instrumentation Laboratory COK200033HemosIL von Willebrand 因子抗原Instrumentation Laboratory CO
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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