FDA 510(k)

xTAG Gastrointestinal Pathogen Panel (GPP)

K-번호: K191161 · 2019-11-12

결정일2019-11-12

제품 코드PCH

자문 위원회미 (Original text: MI)

결정대체적으로 동일

기기 요약

xTAG Gastrointestinal Pathogen Panel (GPP) is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Molecular Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-11-12 under 510(k) number K191161. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the xTAG Gastrointestinal Pathogen Panel (GPP)?

xTAG Gastrointestinal Pathogen Panel (GPP) is a medical device that received FDA 510(k) clearance on 2019-11-12. The listed applicant is Luminex Molecular Diagnostics, Inc.. The 510(k) number is K191161.

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

xTAG Gastrointestinal Pathogen Panel (GPP) received FDA 510(k) clearance on 2019-11-12, under 510(k) number K191161.

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

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

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

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

Luminex Molecular Diagnostics, Inc.를 신청인으로 등재한 기타 기록

K242613NxTAG® 호흡기 감염 원인 패널 K231758NxTAG 호흡기 감염 원인 패널 v2 (NxTAG RPP v2)K193167NxTAG 호흡기 감염 원인 패널, NxTAG 호흡기 감염 원인 패널 파일, SYNCT 소프트웨어 K191160xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)K183030xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)K183023xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)

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