FDA 510(k)

VITROS 免疫诊断产品 CK-MB 试剂套装

K号: K212648 · 2022-01-28

决定日期2022-01-28

产品代码JHX

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

VITROS Immunodiagnostic Products CK-MB Reagent Pack is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Clinical Diagnostics. It received FDA 510(k) clearance on 2022-01-28 under 510(k) number K212648. The device is classified under product code JHX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VITROS Immunodiagnostic Products CK-MB Reagent Pack?

VITROS Immunodiagnostic Products CK-MB Reagent Pack is a medical device that received FDA 510(k) clearance on 2022-01-28. The listed applicant is Ortho Clinical Diagnostics. The 510(k) number is K212648.

When did VITROS Immunodiagnostic Products CK-MB Reagent Pack receive FDA 510(k) clearance?

VITROS Immunodiagnostic Products CK-MB Reagent Pack received FDA 510(k) clearance on 2022-01-28, under 510(k) number K212648.

Who is the listed applicant for VITROS Immunodiagnostic Products CK-MB Reagent Pack?

The FDA 510(k) record lists Ortho Clinical Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITROS Immunodiagnostic Products CK-MB Reagent Pack?

The FDA product code for VITROS Immunodiagnostic Products CK-MB Reagent Pack is JHX.

列明Ortho Clinical Diagnostics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。

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官方来源

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