醫學設備註冊文本翻譯： MediLab
K 號：K221065 · 2022-06-10
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器材摘要
MediLab is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Scientific Services, LLC. It received FDA 510(k) clearance on 2022-06-10 under 510(k) number K221065. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the MediLab?
MediLab is a medical device that received FDA 510(k) clearance on 2022-06-10. The listed applicant is Sigma Scientific Services, LLC. The 510(k) number is K221065.
When did MediLab receive FDA 510(k) clearance?
MediLab received FDA 510(k) clearance on 2022-06-10, under 510(k) number K221065.
Who is the listed applicant for MediLab?
The FDA 510(k) record lists Sigma Scientific Services, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MediLab?
The FDA product code for MediLab is LLZ.
相關臨床試驗
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相關器械（代碼：LLZ）
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。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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