FDA 510(k)

VITROS BRAHMS PCT试剂包和校准器

K号: K200236 · 2020-02-25

决定日期2020-02-25

产品代码PMT

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决定实质等同

器械摘要

VITROS BRAHMS PCT Reagent Pack and Calibrators 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 2020-02-25 under 510(k) number K200236. The device is classified under product code PMT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VITROS BRAHMS PCT Reagent Pack and Calibrators?

VITROS BRAHMS PCT Reagent Pack and Calibrators is a medical device that received FDA 510(k) clearance on 2020-02-25. The listed applicant is Ortho Clinical Diagnostics. The 510(k) number is K200236.

When did VITROS BRAHMS PCT Reagent Pack and Calibrators receive FDA 510(k) clearance?

VITROS BRAHMS PCT Reagent Pack and Calibrators received FDA 510(k) clearance on 2020-02-25, under 510(k) number K200236.

Who is the listed applicant for VITROS BRAHMS PCT Reagent Pack and Calibrators?

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 BRAHMS PCT Reagent Pack and Calibrators?

The FDA product code for VITROS BRAHMS PCT Reagent Pack and Calibrators is PMT.

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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