滴管 hsCRP 高敏感度 CRP 控制器
K 號：K152117 · 2016-04-21
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器材摘要
Dropper hsCRP High Sensitivity CRP Control is the device name listed in this FDA 510(k) record. The listed applicant is Quantimetrix Corporation. It received FDA 510(k) clearance on 2016-04-21 under 510(k) number K152117. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Dropper hsCRP High Sensitivity CRP Control?
Dropper hsCRP High Sensitivity CRP Control is a medical device that received FDA 510(k) clearance on 2016-04-21. The listed applicant is Quantimetrix Corporation. The 510(k) number is K152117.
When did Dropper hsCRP High Sensitivity CRP Control receive FDA 510(k) clearance?
Dropper hsCRP High Sensitivity CRP Control received FDA 510(k) clearance on 2016-04-21, under 510(k) number K152117.
Who is the listed applicant for Dropper hsCRP High Sensitivity CRP Control?
The FDA 510(k) record lists Quantimetrix Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Dropper hsCRP High Sensitivity CRP Control?
The FDA product code for Dropper hsCRP High Sensitivity CRP Control is JJX.
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相關器械（代碼：JJX）
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
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