FDA 510(k)

Healgen 醫療設備快速檢測條（喉嚨拭子）

K 號：K212623 · 2022-03-16

決定日期2022-03-16

產品代碼GTY

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

Healgen Strep A Rapid Test Strip (Throat Swab) is the device name listed in this FDA 510(k) record. The listed applicant is Healgen Scientific,, LLC. It received FDA 510(k) clearance on 2022-03-16 under 510(k) number K212623. The device is classified under product code GTY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Healgen Strep A Rapid Test Strip (Throat Swab)?

Healgen Strep A Rapid Test Strip (Throat Swab) is a medical device that received FDA 510(k) clearance on 2022-03-16. The listed applicant is Healgen Scientific,, LLC. The 510(k) number is K212623.

When did Healgen Strep A Rapid Test Strip (Throat Swab) receive FDA 510(k) clearance?

Healgen Strep A Rapid Test Strip (Throat Swab) received FDA 510(k) clearance on 2022-03-16, under 510(k) number K212623.

Who is the listed applicant for Healgen Strep A Rapid Test Strip (Throat Swab)?

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

What is the FDA product code for Healgen Strep A Rapid Test Strip (Throat Swab)?

The FDA product code for Healgen Strep A Rapid Test Strip (Throat Swab) is GTY.

其他以 Healgen Scientific,, LLC 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。

K260095治康快速COVID-19抗原自測包 K253705Healgen®精準口腔濾液藥物檢測 K252523Healgen®精準口腔濾液藥物檢測COT/THC；Healgen®精準口腔濾液藥物檢測 K253567Healgen精準尿液藥物檢測濾卡；Healgen精準家庭尿液藥物檢測濾卡 K251800Healgen® URS測試條 K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)測試套件 - 定性；Healgen® 免疫荧光分析儀（OG-H180）

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相關器械（代碼：GTY）

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。

K260342AllTest Strep A Rapid TestHangzhou AllTest Biotech Co., Ltd.K251697Flowflex® Plus 醍醐A 快速測試條；Flowflex® Plus 醍醐A 快速測試卡ACON Laboratories, Inc.K171976索菲亞肺炎鏈球菌A+ FIA，索菲亞2分析儀Quidel Corporation

官方來源

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