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FDA 510(k)

CaseBio™ 綠色培養液/含人血清白蛋白 (CMH5)；CaseBio™ 操控/含人血清白蛋白 (WHH5)

K 號：K252672 · 2026-02-20

申請人Casebioscience, Inc.
決定日期2026-02-20
產品代碼MQL
諮詢委員會OB設備之醫療設備規範文本翻譯如下： 關於OB設備的醫療設備規範文件： 此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址： 識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1
決定相當於

器材摘要

CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5) is the device name listed in this FDA 510(k) record. The listed applicant is Casebioscience, Inc.. It received FDA 510(k) clearance on 2026-02-20 under 510(k) number K252672. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)?

CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5) is a medical device that received FDA 510(k) clearance on 2026-02-20. The listed applicant is Casebioscience, Inc.. The 510(k) number is K252672.

When did CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5) receive FDA 510(k) clearance?

CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5) received FDA 510(k) clearance on 2026-02-20, under 510(k) number K252672.

Who is the listed applicant for CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)?

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

What is the FDA product code for CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)?

The FDA product code for CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5) is MQL.

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 Casebioscience, 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。

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相關器械（代碼：MQL）

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官方來源

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