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FDA 510(k)

AllergiEnd ST-9 多次皮膚試驗應用器，AllergiEnd ST-9 多次孔試驗板

K 號：K172062 · 2018-03-05

申請人Medscience Science Research Group, Inc.
決定日期2018-03-05
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

AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray is the device name listed in this FDA 510(k) record. The listed applicant is Medscience Science Research Group, Inc.. It received FDA 510(k) clearance on 2018-03-05 under 510(k) number K172062. 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 AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray?

AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray is a medical device that received FDA 510(k) clearance on 2018-03-05. The listed applicant is Medscience Science Research Group, Inc.. The 510(k) number is K172062.

When did AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray receive FDA 510(k) clearance?

AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray received FDA 510(k) clearance on 2018-03-05, under 510(k) number K172062.

Who is the listed applicant for AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray?

The FDA 510(k) record lists Medscience Science Research Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray?

The FDA product code for AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray is SCL.

相關臨床試驗

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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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。

K250983Medblue皮內試驗應用器（AS103、AS108、AS109、AS110、AS111、AS113、AS132、AS134、AS146、AS148、AS160、AS162、AS170、AS172）Asistan MedikalK222385分叉針Anhui Tiankang Medical Technology Co., Ltd.K182582Oryum與Ovem表皮皮膚針刺試驗應用器Allergy & Applicator Depot, LLCK162917Allerhope 過敏性皮膚測試器Procare Industrial Co., Limited

官方來源

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