FDA 510(k)

酶填充針筒 - RELiZORB

K 號：K231156 · 2023-08-30

決定日期2023-08-30

產品代碼PLQ

諮詢委員會GU

決定相當於

器材摘要

Enzyme Packed Cartridge - RELiZORB is the device name listed in this FDA 510(k) record. The listed applicant is Alcresta Therapeutics, Inc.. It received FDA 510(k) clearance on 2023-08-30 under 510(k) number K231156. The device is classified under product code PLQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Enzyme Packed Cartridge - RELiZORB?

Enzyme Packed Cartridge - RELiZORB is a medical device that received FDA 510(k) clearance on 2023-08-30. The listed applicant is Alcresta Therapeutics, Inc.. The 510(k) number is K231156.

When did Enzyme Packed Cartridge - RELiZORB receive FDA 510(k) clearance?

Enzyme Packed Cartridge - RELiZORB received FDA 510(k) clearance on 2023-08-30, under 510(k) number K231156.

Who is the listed applicant for Enzyme Packed Cartridge - RELiZORB?

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

What is the FDA product code for Enzyme Packed Cartridge - RELiZORB?

The FDA product code for Enzyme Packed Cartridge - RELiZORB is PLQ.

其他以 Alcresta Therapeutics, Inc. 為申請人之記錄

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。

K250499RELiZORB (100300/100301)K243284RELiZORB (100300/ 100301)K232784RELiZORB®K191379RELiZORB K163057Relizorb K161247Relizorb

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相關器械（代碼：PLQ）

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。

K250499RELiZORB (100300/100301)Alcresta Therapeutics, Inc.K243284RELiZORB (100300/ 100301)Alcresta Therapeutics, Inc.K232784RELiZORB®Alcresta Therapeutics, Inc.K191379RELiZORBAlcresta Therapeutics, Inc.K163057RelizorbAlcresta Therapeutics, Inc.K161247RelizorbAlcresta Therapeutics, Inc.

官方來源

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