FDA 510(k)

免疫卡統計！HpSA

K 號：K153661 · 2016-03-14

決定日期2016-03-14

產品代碼LYR

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

ImmunoCard STAT! HpSA is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Bioscience, Inc.. It received FDA 510(k) clearance on 2016-03-14 under 510(k) number K153661. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ImmunoCard STAT! HpSA?

ImmunoCard STAT! HpSA is a medical device that received FDA 510(k) clearance on 2016-03-14. The listed applicant is Meridian Bioscience, Inc.. The 510(k) number is K153661.

When did ImmunoCard STAT! HpSA receive FDA 510(k) clearance?

ImmunoCard STAT! HpSA received FDA 510(k) clearance on 2016-03-14, under 510(k) number K153661.

Who is the listed applicant for ImmunoCard STAT! HpSA?

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

What is the FDA product code for ImmunoCard STAT! HpSA?

The FDA product code for ImmunoCard STAT! HpSA is LYR.

其他以 Meridian Bioscience, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K243922Revogene K230901預設 HpSA Flex (619096)K222829Curian® 肽毒素 K222779Revogene K220480Revogene K210976Curian Campy

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相關器械（代碼：LYR）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K232892Hp Detect™ 粪便抗原ELISABiomerica, Inc.K230901預設 HpSA Flex (619096)Meridian Bioscience, Inc.K192817Curian HpSA，Curian 分析儀Meridian Bioscience, Inc.K183573Vstrip 幽門螺桿菌抗原快速檢測Panion & BF Biotech, Inc.K182559預約者白金HpSA PLUSMeridian Bioscience, Inc.K181464LIAISON幽門螺桿抗原，LIAISON幽門螺桿抗原控制組DiaSorin, Inc.

官方來源

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