Lucica 糖化白蛋白-L
K 號：K170147 · 2017-10-12
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器材摘要
Lucica Glycated Albumin-L is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Kasei Pharma Corporation. It received FDA 510(k) clearance on 2017-10-12 under 510(k) number K170147. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Lucica Glycated Albumin-L?
Lucica Glycated Albumin-L is a medical device that received FDA 510(k) clearance on 2017-10-12. The listed applicant is Asahi Kasei Pharma Corporation. The 510(k) number is K170147.
When did Lucica Glycated Albumin-L receive FDA 510(k) clearance?
Lucica Glycated Albumin-L received FDA 510(k) clearance on 2017-10-12, under 510(k) number K170147.
Who is the listed applicant for Lucica Glycated Albumin-L?
The FDA 510(k) record lists Asahi Kasei Pharma Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Lucica Glycated Albumin-L?
The FDA product code for Lucica Glycated Albumin-L is LCP.
相關臨床試驗
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相關器械（代碼：LCP）
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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