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FDA 510(k)

PanNAT 大腸桿菌檢測

K 號：K173330 · 2018-06-01

申請人Micronics, Inc.
決定日期2018-06-01
產品代碼PCI
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

PanNAT STEC Test is the device name listed in this FDA 510(k) record. The listed applicant is Micronics, Inc.. It received FDA 510(k) clearance on 2018-06-01 under 510(k) number K173330. The device is classified under product code PCI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PanNAT STEC Test?

PanNAT STEC Test is a medical device that received FDA 510(k) clearance on 2018-06-01. The listed applicant is Micronics, Inc.. The 510(k) number is K173330.

When did PanNAT STEC Test receive FDA 510(k) clearance?

PanNAT STEC Test received FDA 510(k) clearance on 2018-06-01, under 510(k) number K173330.

Who is the listed applicant for PanNAT STEC Test?

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

What is the FDA product code for PanNAT STEC Test?

The FDA product code for PanNAT STEC Test is PCI.

相關臨床試驗

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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相關器械（代碼：PCI）

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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