FDA 510(k)

DRI TM 三环类血清毒物检测

K号: K213875 · 2022-12-21

决定日期2022-12-21

产品代码LFH

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决定实质等同

器械摘要

DRI TM Tricyclics Serum Tox Assay is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corporation. It received FDA 510(k) clearance on 2022-12-21 under 510(k) number K213875. The device is classified under product code LFH. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DRI TM Tricyclics Serum Tox Assay?

DRI TM Tricyclics Serum Tox Assay is a medical device that received FDA 510(k) clearance on 2022-12-21. The listed applicant is Microgenics Corporation. The 510(k) number is K213875.

When did DRI TM Tricyclics Serum Tox Assay receive FDA 510(k) clearance?

DRI TM Tricyclics Serum Tox Assay received FDA 510(k) clearance on 2022-12-21, under 510(k) number K213875.

Who is the listed applicant for DRI TM Tricyclics Serum Tox Assay?

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

What is the FDA product code for DRI TM Tricyclics Serum Tox Assay?

The FDA product code for DRI TM Tricyclics Serum Tox Assay is LFH.

列明Microgenics Corporation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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