CRYOcheck Chromogenic Factor IX
K号: K214002 · 2022-12-23
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决定日期2022-12-23
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
CRYOcheck Chromogenic Factor IX is the device name listed in this FDA 510(k) record. The listed applicant is Precision Biologic, Inc.. It received FDA 510(k) clearance on 2022-12-23 under 510(k) number K214002. 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 CRYOcheck Chromogenic Factor IX?
CRYOcheck Chromogenic Factor IX is a medical device that received FDA 510(k) clearance on 2022-12-23. The listed applicant is Precision Biologic, Inc.. The 510(k) number is K214002.
When did CRYOcheck Chromogenic Factor IX receive FDA 510(k) clearance?
CRYOcheck Chromogenic Factor IX received FDA 510(k) clearance on 2022-12-23, under 510(k) number K214002.
Who is the listed applicant for CRYOcheck Chromogenic Factor IX?
The FDA 510(k) record lists Precision Biologic, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CRYOcheck Chromogenic Factor IX?
The FDA product code for CRYOcheck Chromogenic Factor IX is GGP.
相关临床试验
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列明Precision Biologic, Inc.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 GmbHK223402HemosIL von Willebrand 因子抗原Instrumentation Laboratory COK200033HemosIL von Willebrand 因子抗原Instrumentation Laboratory COK193204Cryocheck 酶联因子VIIIPrecision Biologic
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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