FDA 510(k)

Biocode 消化道病原體面板（GPP）

K 號：K190585 · 2019-06-05

決定日期2019-06-05

產品代碼PCH

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

Biocode Gastrointestinal Pathogen Panel (GPP) is the device name listed in this FDA 510(k) record. The listed applicant is Applied BioCode, Inc.. It received FDA 510(k) clearance on 2019-06-05 under 510(k) number K190585. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Biocode Gastrointestinal Pathogen Panel (GPP)?

Biocode Gastrointestinal Pathogen Panel (GPP) is a medical device that received FDA 510(k) clearance on 2019-06-05. The listed applicant is Applied BioCode, Inc.. The 510(k) number is K190585.

When did Biocode Gastrointestinal Pathogen Panel (GPP) receive FDA 510(k) clearance?

Biocode Gastrointestinal Pathogen Panel (GPP) received FDA 510(k) clearance on 2019-06-05, under 510(k) number K190585.

Who is the listed applicant for Biocode Gastrointestinal Pathogen Panel (GPP)?

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

What is the FDA product code for Biocode Gastrointestinal Pathogen Panel (GPP)?

The FDA product code for Biocode Gastrointestinal Pathogen Panel (GPP) is PCH.

其他以 Applied BioCode, Inc. 為申請人之記錄

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。

K254139BioCode® 呼吸道病原體面板 (RPP)K242877BioCode 消化道病原體面板 (GPP)K192485生物碼呼吸病原體面板（RPP）K180041BioCode 消化道病原體面板 (GPP)

相關器械（代碼：PCH）

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。

K253722LIAISON PLEX 消化道柔軟性試驗Luminex Corporation K254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH K251721Xpert GI PanelCepheid K252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH K251993山貓融合內分泌系統廣範細菌試驗Hologic, Inc.K251868山貓融合胃腸細菌試驗Hologic

官方來源

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