FDA 510(k)

Synermed 吗啡酶免疫測試

K 號：K172416 · 2018-04-19

申請人Infrared Laboratory Systems, LLC (Dba Synermed)

決定日期2018-04-19

產品代碼DJG

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決定相當於

器材摘要

Synermed Opiate Enzyme Immunoassay is the device name listed in this FDA 510(k) record. The listed applicant is Infrared Laboratory Systems, LLC (Dba Synermed). It received FDA 510(k) clearance on 2018-04-19 under 510(k) number K172416. 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 Synermed Opiate Enzyme Immunoassay?

Synermed Opiate Enzyme Immunoassay is a medical device that received FDA 510(k) clearance on 2018-04-19. The listed applicant is Infrared Laboratory Systems, LLC (Dba Synermed). The 510(k) number is K172416.

When did Synermed Opiate Enzyme Immunoassay receive FDA 510(k) clearance?

Synermed Opiate Enzyme Immunoassay received FDA 510(k) clearance on 2018-04-19, under 510(k) number K172416.

Who is the listed applicant for Synermed Opiate Enzyme Immunoassay?

The FDA 510(k) record lists Infrared Laboratory Systems, LLC (Dba Synermed) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synermed Opiate Enzyme Immunoassay?

The FDA product code for Synermed Opiate Enzyme Immunoassay is DJG.

其他以 Infrared Laboratory Systems, LLC (Dba Synermed) 為申請人之記錄

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相關器械（代碼：DJG）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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