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FDA 510(k)

UCP 細胞組織藥物測試

K 號:K152908 · 2016-05-03

決定日期2016-05-03
產品代碼DKZ
諮詢委員會此醫療器材法規描述涉及FDA、510(k)、PMA、NCT、PMID及相關網址,以下為繁體中文翻譯: 本醫療器材之監管狀態係依據美國食品藥物管理局(FDA)之相關規定,包括510(k)上市前通知及PMA上市前核准程序。相關臨床試驗資訊可參閱NCT編號及PMID文獻編號,詳細資料請見所附網址。
決定相當於

器材摘要

UCP COMPACT DRUG TESTS is the device name listed in this FDA 510(k) record. The listed applicant is Ucp Biosciences, Inc.. It received FDA 510(k) clearance on 2016-05-03 under 510(k) number K152908. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the UCP COMPACT DRUG TESTS?

UCP COMPACT DRUG TESTS is a medical device that received FDA 510(k) clearance on 2016-05-03. The listed applicant is Ucp Biosciences, Inc.. The 510(k) number is K152908.

When did UCP COMPACT DRUG TESTS receive FDA 510(k) clearance?

UCP COMPACT DRUG TESTS received FDA 510(k) clearance on 2016-05-03, under 510(k) number K152908.

Who is the listed applicant for UCP COMPACT DRUG TESTS?

The FDA 510(k) record lists Ucp Biosciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UCP COMPACT DRUG TESTS?

The FDA product code for UCP COMPACT DRUG TESTS is DKZ.

相關臨床試驗

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相關器械(代碼:DKZ)

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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