FDA 510(k)

BIOFIRE FILMARRAY 消化器系（GI）パネル中

K番号: K243885 · 2025-01-16

決定日2025-01-16

製品コードPCH

諮問委員会以下は、提供された医療機器規制テキストの日本語訳です。 --- MI --- URLや識別子などは原文のままです。

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてBiofire Diagnostics, LLCを記載するその他の記録

K243544BIOFIRE SPOTFIRE 呼吸器/扁桃体炎パネルミニ K243759BIOFIRE 血液培養識別 2 (BCID2) パネル（RFIT-ASY-0147（30パック）RFIT-ASY-0148（6パック））K242367BIOFIRE FILMARRAY 消化器系（GI）パネル K241194BIOFIRE SPOTFIRE 呼吸器/扁桃体炎（R/ST）パネルミニ K232954BIOFIRE SPOTFIRE 呼吸器/扁桃体炎（R/ST）パネル K230719BIOFIRE® SPOTFIRE® 呼吸器（R）パネルミニ

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