FDA 510(k)

BIOFIRE FILMARRAY 胃肠道（GI）检测板中

K号: K243885 · 2025-01-16

决定日期2025-01-16

产品代码PCH

咨询委员会抱歉，您提供的内容“MI”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid 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 2025-01-16 under 510(k) number K243885. 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 Mid?

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid is a medical device that received FDA 510(k) clearance on 2025-01-16. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K243885.

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

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid received FDA 510(k) clearance on 2025-01-16, under 510(k) number K243885.

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

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 Mid?

The FDA product code for BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid 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 K243759BIOFIRE血培养鉴定2（BCID2）面板（RFIT-ASY-0147（30包装）RFIT-ASY-0148（6包装））K242367BIOFIRE FILMARRAY胃肠道（GI）面板 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

查看所有 20 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。