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FDA 510(k)

Medblue皮內試驗應用器（AS103、AS108、AS109、AS110、AS111、AS113、AS132、AS134、AS146、AS148、AS160、AS162、AS170、AS172）

K 號：K250983 · 2026-01-30

申請人Asistan Medikal
決定日期2026-01-30
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

Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) is the device name listed in this FDA 510(k) record. The listed applicant is Asistan Medikal. It received FDA 510(k) clearance on 2026-01-30 under 510(k) number K250983. 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 Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)?

Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) is a medical device that received FDA 510(k) clearance on 2026-01-30. The listed applicant is Asistan Medikal. The 510(k) number is K250983.

When did Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) receive FDA 510(k) clearance?

Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) received FDA 510(k) clearance on 2026-01-30, under 510(k) number K250983.

Who is the listed applicant for Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)?

The FDA 510(k) record lists Asistan Medikal as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)?

The FDA product code for Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) 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。

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官方來源

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