FDA 510(k)

TRI-COMBO寄生蟲檢測器

K 號：K171078 · 2017-07-10

決定日期2017-07-10

產品代碼MHJ

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

TRI-COMBO PARASITE SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Techlab, Inc.. It received FDA 510(k) clearance on 2017-07-10 under 510(k) number K171078. The device is classified under product code MHJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TRI-COMBO PARASITE SCREEN?

TRI-COMBO PARASITE SCREEN is a medical device that received FDA 510(k) clearance on 2017-07-10. The listed applicant is Techlab, Inc.. The 510(k) number is K171078.

When did TRI-COMBO PARASITE SCREEN receive FDA 510(k) clearance?

TRI-COMBO PARASITE SCREEN received FDA 510(k) clearance on 2017-07-10, under 510(k) number K171078.

Who is the listed applicant for TRI-COMBO PARASITE SCREEN?

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

What is the FDA product code for TRI-COMBO PARASITE SCREEN?

The FDA product code for TRI-COMBO PARASITE SCREEN is MHJ.

其他以 Techlab, Inc. 為申請人之記錄

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器材摘要

常見問題

相關臨床試驗

其他以 Techlab, Inc. 為申請人之記錄

官方來源