FDA 510(k)

Access PCT, Access PCT 定标器

K号: K192271 · 2019-11-26

决定日期2019-11-26

产品代码PTF

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决定实质等同

器械摘要

Access PCT, Access PCT Calibrators is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2019-11-26 under 510(k) number K192271. The device is classified under product code PTF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Access PCT, Access PCT Calibrators?

Access PCT, Access PCT Calibrators is a medical device that received FDA 510(k) clearance on 2019-11-26. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K192271.

When did Access PCT, Access PCT Calibrators receive FDA 510(k) clearance?

Access PCT, Access PCT Calibrators received FDA 510(k) clearance on 2019-11-26, under 510(k) number K192271.

Who is the listed applicant for Access PCT, Access PCT Calibrators?

FDA 510(k)记录中列出Beckman Coulter, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Access PCT, Access PCT Calibrators?

The FDA product code for Access PCT, Access PCT Calibrators is PTF.

列明Beckman Coulter, 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。

K262109Access NT-proBNP K252169Access BNP II K254059Access 乙型肝炎核心抗体IgM K253687Access 乙型肝炎核心抗体总抗体 K251995Access 乙型肝炎核心抗体IgM K250588Access 风疹IgG

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官方来源

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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。