FDA 510(k)

BioCode 胃肠道病原体检测板 (GPP)

K号: K180041 · 2018-09-28

决定日期2018-09-28

产品代码PCH

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决定实质等同

器械摘要

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 2018-09-28 under 510(k) number K180041. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BioCode Gastrointestinal Pathogen Panel (GPP)?

BioCode Gastrointestinal Pathogen Panel (GPP) is a medical device that received FDA 510(k) clearance on 2018-09-28. The listed applicant is Applied BioCode, Inc.. The 510(k) number is K180041.

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

BioCode Gastrointestinal Pathogen Panel (GPP) received FDA 510(k) clearance on 2018-09-28, under 510(k) number K180041.

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.

列明Applied BioCode, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K254139BioCode® 呼吸道病原体检测板 (RPP)K242877BioCode 胃肠道病原体检测板 (GPP)K192485BioCode 呼吸道病原体检测板 (RPP)K190585Biocode胃肠道病原体检测板（GPP）

官方来源

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