FDA 510(k)

OHC COVID-19 抗原自測包

K 號：K241313 · 2025-05-30

決定日期2025-05-30

產品代碼QYT

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

OHC COVID-19 Antigen Self Test is the device name listed in this FDA 510(k) record. The listed applicant is Osang, LLC. It received FDA 510(k) clearance on 2025-05-30 under 510(k) number K241313. The device is classified under product code QYT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OHC COVID-19 Antigen Self Test?

OHC COVID-19 Antigen Self Test is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Osang, LLC. The 510(k) number is K241313.

When did OHC COVID-19 Antigen Self Test receive FDA 510(k) clearance?

OHC COVID-19 Antigen Self Test received FDA 510(k) clearance on 2025-05-30, under 510(k) number K241313.

Who is the listed applicant for OHC COVID-19 Antigen Self Test?

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

What is the FDA product code for OHC COVID-19 Antigen Self Test?

The FDA product code for OHC COVID-19 Antigen Self Test is QYT.

其他以 Osang, 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。

K243262QuickFinder COVID-19/流感抗原自測 / QuickFinder COVID-19/流感抗原專測

相關器械（代碼：QYT）

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。

K260754Fastep COVID-19 抗原筆式家庭檢測；Fastep COVID-19 抗原筆式檢測Assure Tech., LLC K260095治康快速COVID-19抗原自測包Healgen Scientific,, LLC K251916GenBody COVID-19 Ag 家庭檢測Genbody.Inc.K251595COVID-19 快速自測檢測器InBios International, Inc.K251753GenaCheck COVID-19 快速自測包Genabio Diagnostics, Inc.K243518BinaxNOW™ COVID-19 抗原自測包Abbott Diagnostics Scarborough, Inc.

官方來源

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