FDA 510(k)

Immunalysis乙醇酶联免疫测定

K号: K181553 · 2018-10-31

决定日期2018-10-31

产品代码DIC

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决定实质等同

器械摘要

Immunalysis Ethyl Alcohol Enzyme Assay is the device name listed in this FDA 510(k) record. The listed applicant is Immunalysis Corporation. It received FDA 510(k) clearance on 2018-10-31 under 510(k) number K181553. The device is classified under product code DIC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Immunalysis Ethyl Alcohol Enzyme Assay?

Immunalysis Ethyl Alcohol Enzyme Assay is a medical device that received FDA 510(k) clearance on 2018-10-31. The listed applicant is Immunalysis Corporation. The 510(k) number is K181553.

When did Immunalysis Ethyl Alcohol Enzyme Assay receive FDA 510(k) clearance?

Immunalysis Ethyl Alcohol Enzyme Assay received FDA 510(k) clearance on 2018-10-31, under 510(k) number K181553.

Who is the listed applicant for Immunalysis Ethyl Alcohol Enzyme Assay?

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

What is the FDA product code for Immunalysis Ethyl Alcohol Enzyme Assay?

The FDA product code for Immunalysis Ethyl Alcohol Enzyme Assay is DIC.

列明Immunalysis Corporation为申报人的其他记录

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