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FDA 510(k)

Hp Detect™ 粪便抗原ELISA

K 號：K232892 · 2023-12-15

申請人Biomerica, Inc.
決定日期2023-12-15
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

Hp Detect™ Stool Antigen ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Biomerica, Inc.. It received FDA 510(k) clearance on 2023-12-15 under 510(k) number K232892. 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 Hp Detect™ Stool Antigen ELISA?

Hp Detect™ Stool Antigen ELISA is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is Biomerica, Inc.. The 510(k) number is K232892.

When did Hp Detect™ Stool Antigen ELISA receive FDA 510(k) clearance?

Hp Detect™ Stool Antigen ELISA received FDA 510(k) clearance on 2023-12-15, under 510(k) number K232892.

Who is the listed applicant for Hp Detect™ Stool Antigen ELISA?

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

What is the FDA product code for Hp Detect™ Stool Antigen ELISA?

The FDA product code for Hp Detect™ Stool Antigen ELISA is LYR.

相關臨床試驗

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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。

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.K181379H. PYLORI 快檢Techlab, Inc.

官方來源

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