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FDA 510(k)

STERLINK mini 高溫滅菌器搭配 STERLOAD mini 載物盒，Tyvek 滑動紙卷 CI 用於 STERLINK 滅菌器，STERLINK 滅菌器滅菌過程指示器；Terragene Bionova SCBI (BT96)，Terragene Bionova 閱讀器培養箱 (IC10/20FRLCD，Mini-Bio)，Terragene Chemdye (CD42)，Terragene Cintape (CT40)

K 號：K220345 · 2023-04-14

申請人Plasmapp Co,., Ltd.
決定日期2023-04-14
產品代碼MLR
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

STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) is the device name listed in this FDA 510(k) record. The listed applicant is Plasmapp Co,., Ltd.. It received FDA 510(k) clearance on 2023-04-14 under 510(k) number K220345. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)?

STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) is a medical device that received FDA 510(k) clearance on 2023-04-14. The listed applicant is Plasmapp Co,., Ltd.. The 510(k) number is K220345.

When did STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) receive FDA 510(k) clearance?

STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) received FDA 510(k) clearance on 2023-04-14, under 510(k) number K220345.

Who is the listed applicant for STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)?

The FDA 510(k) record lists Plasmapp Co,., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)?

The FDA product code for STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) is MLR.

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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其他以 Plasmapp Co,., Ltd. 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。

K231169STERLINK plus 過濾器，配備 STERLOAD 盒，Tyvek 卷材，CI 用於 STERLINK 過濾器，Terragene Bionova SCBI (BT96)，Terragene Bionova 閱讀器培養箱 (IC10/20FRLCD，Mini-bio)，Terragene Chemdye (CD42)，Terragene Cintape (CT40)K223025泰維克卷材，供STERLINK消毒器使用K223015STERLINK™ FPS-15s Plus 消毒器配 STERPACK™ plus 盒K223023Terragene Bionava SCBI (BT96)，Terragene Bionova Reader Incubators (IC10/20FRLCD、Mini-bio)，Terragene Chemdye (CD42)，Terragene Cintape (CT40)K212193Terragene Bionova SCBI (BT96)，Terragene Bionova 閱讀孵育器 (IC10/20FRLCD、迷你-bio)，Terragene Chemdye (CD42)，Terragene Cintape (CT40)K212200STERLINK™ FPS-15s Plus 過濾器，配備 STERLOAD™ 盒

查看所有 8 項裝置 →

相關器械（代碼：MLR）

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。

K252843STERRAD 100NX 消毒系統搭配 ALLClear 技術（10104）Advanced Sterilization Products, Inc.K250802STERRAD® 100NX 高效滅菌器搭配 ALLClear™ 技術（10104）Advanced Sterilization Products, Inc.K231893LOWTEM 晶體 120Lowtem Co., Ltd.K234082STERRAD® 100NX 消毒器搭配 ALLClear™ 技術及 ULTRA GI™ 循環 (10104)；APTIMAX™ 裝置盤適用於 ULTRA GI™ 循環 (011077)Advanced Sterilization ProductsK233762Stereoscope® 過濾技術系統Ideate Medical, Inc.K233065V-PRO maX 2 低溫消毒系統Steris

官方來源

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