生物標記nPoint
K 號：K173510 · 2018-05-08
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器材摘要
BioStamp nPoint is the device name listed in this FDA 510(k) record. The listed applicant is Mc10, Inc.. It received FDA 510(k) clearance on 2018-05-08 under 510(k) number K173510. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the BioStamp nPoint?
BioStamp nPoint is a medical device that received FDA 510(k) clearance on 2018-05-08. The listed applicant is Mc10, Inc.. The 510(k) number is K173510.
When did BioStamp nPoint receive FDA 510(k) clearance?
BioStamp nPoint received FDA 510(k) clearance on 2018-05-08, under 510(k) number K173510.
Who is the listed applicant for BioStamp nPoint?
The FDA 510(k) record lists Mc10, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BioStamp nPoint?
The FDA product code for BioStamp nPoint is DRG.
相關臨床試驗
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相關器械（代碼：DRG）
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。
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官方來源
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