FDA 510(k)

ARK 甲氨蝶呤测定法

K号: K163359 · 2017-08-18

决定日期2017-08-18

产品代码LAO

决定实质等同

器械摘要

ARK Methotrexate Assay is the device name listed in this FDA 510(k) record. The listed applicant is Ark Diagnostics, Inc.. It received FDA 510(k) clearance on 2017-08-18 under 510(k) number K163359. The device is classified under product code LAO. FDA Decision: Substantially Equivalent.

常见问题

What is the ARK Methotrexate Assay?

ARK Methotrexate Assay is a medical device that received FDA 510(k) clearance on 2017-08-18. The listed applicant is Ark Diagnostics, Inc.. The 510(k) number is K163359.

When did ARK Methotrexate Assay receive FDA 510(k) clearance?

ARK Methotrexate Assay received FDA 510(k) clearance on 2017-08-18, under 510(k) number K163359.

Who is the listed applicant for ARK Methotrexate Assay?

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

What is the FDA product code for ARK Methotrexate Assay?

The FDA product code for ARK Methotrexate Assay is LAO.

列明Ark Diagnostics, 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。

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官方来源

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