Allerhope 過敏性皮膚測試器
K 號：K162917 · 2017-08-17
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決定日期2017-08-17
產品代碼SCL
諮詢委員會醫療設備規範文本翻譯如下：
HO
注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於
器材摘要
Allerhope Allergy Skin Tester is the device name listed in this FDA 510(k) record. The listed applicant is Procare Industrial Co., Limited. It received FDA 510(k) clearance on 2017-08-17 under 510(k) number K162917. The device is classified under product code SCL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Allerhope Allergy Skin Tester?
Allerhope Allergy Skin Tester is a medical device that received FDA 510(k) clearance on 2017-08-17. The listed applicant is Procare Industrial Co., Limited. The 510(k) number is K162917.
When did Allerhope Allergy Skin Tester receive FDA 510(k) clearance?
Allerhope Allergy Skin Tester received FDA 510(k) clearance on 2017-08-17, under 510(k) number K162917.
Who is the listed applicant for Allerhope Allergy Skin Tester?
The FDA 510(k) record lists Procare Industrial Co., Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Allerhope Allergy Skin Tester?
The FDA product code for Allerhope Allergy Skin Tester is SCL.
相關臨床試驗
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相關器械（代碼：SCL）
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
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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