FDA 510(k)

验证D-二聚体校准验证/线性测试试剂盒

K号: K152961 · 2016-06-03

决定日期2016-06-03

产品代码GGN

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

VALIDATE D-Dimer Calibration Verification/Linearity Test Kit is the device name listed in this FDA 510(k) record. The listed applicant is Maine Standards Company, LLC. It received FDA 510(k) clearance on 2016-06-03 under 510(k) number K152961. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VALIDATE D-Dimer Calibration Verification/Linearity Test Kit?

VALIDATE D-Dimer Calibration Verification/Linearity Test Kit is a medical device that received FDA 510(k) clearance on 2016-06-03. The listed applicant is Maine Standards Company, LLC. The 510(k) number is K152961.

When did VALIDATE D-Dimer Calibration Verification/Linearity Test Kit receive FDA 510(k) clearance?

VALIDATE D-Dimer Calibration Verification/Linearity Test Kit received FDA 510(k) clearance on 2016-06-03, under 510(k) number K152961.

Who is the listed applicant for VALIDATE D-Dimer Calibration Verification/Linearity Test Kit?

The FDA 510(k) record lists Maine Standards Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VALIDATE D-Dimer Calibration Verification/Linearity Test Kit?

The FDA product code for VALIDATE D-Dimer Calibration Verification/Linearity Test Kit is GGN.

列明Maine Standards Company, LLC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。

K170864验证D-二聚体校准验证/线性测试试剂盒 K163498验证肝素校准验证/线性测试试剂盒 K162705VALIDATE® D-二聚体校准验证/线性测试试剂盒

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