FDA 510(k)

ARK Tramadol Assay

K 號：K182280 · 2018-12-10

決定日期2018-12-10

產品代碼DJG

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決定相當於

器材摘要

ARK Tramadol 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 2018-12-10 under 510(k) number K182280. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ARK Tramadol Assay?

ARK Tramadol Assay is a medical device that received FDA 510(k) clearance on 2018-12-10. The listed applicant is Ark Diagnostics, Inc.. The 510(k) number is K182280.

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

ARK Tramadol Assay received FDA 510(k) clearance on 2018-12-10, under 510(k) number K182280.

Who is the listed applicant for ARK Tramadol 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 Tramadol Assay?

The FDA product code for ARK Tramadol Assay is DJG.

其他以 Ark Diagnostics, Inc. 為申請人之記錄

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相關器械（代碼：DJG）

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