FDA 510(k)

BIOFIRE FILMARRAY胃肠道（GI）面板

K号: K242367 · 2024-11-07

决定日期2024-11-07

产品代码PCH

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决定实质等同

器械摘要

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is the device name listed in this FDA 510(k) record. The listed applicant is Biofire Diagnostics, LLC. It received FDA 510(k) clearance on 2024-11-07 under 510(k) number K242367. 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 BIOFIRE FILMARRAY Gastrointestinal (GI) Panel?

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a medical device that received FDA 510(k) clearance on 2024-11-07. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K242367.

When did BIOFIRE FILMARRAY Gastrointestinal (GI) Panel receive FDA 510(k) clearance?

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel received FDA 510(k) clearance on 2024-11-07, under 510(k) number K242367.

Who is the listed applicant for BIOFIRE FILMARRAY Gastrointestinal (GI) Panel?

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

What is the FDA product code for BIOFIRE FILMARRAY Gastrointestinal (GI) Panel?

The FDA product code for BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is PCH.

列明Biofire Diagnostics, LLC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。

K243544BIOFIRE SPOTFIRE 呼吸道/喉咙痛检测板迷你版 K243885BIOFIRE FILMARRAY 胃肠道（GI）检测板中 K243759BIOFIRE血培养鉴定2（BCID2）面板（RFIT-ASY-0147（30包装）RFIT-ASY-0148（6包装））K241194BIOFIRE SPOTFIRE 呼吸道/喉咙痛（R/ST）检测板迷你版 K232954BIOFIRE SPOTFIRE 呼吸道/喉咙痛（R/ST）检测板 K230719BIOFIRE® SPOTFIRE® 呼吸道（R）检测板迷你版

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