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FDA 510(k)

MetaLite DX 電子病理學軟體

K 號：K240303 · 2024-10-28

申請人Jellox Biotech, Inc.
決定日期2024-10-28
產品代碼QKQ
諮詢委員會PA
決定相當於

器材摘要

MetaLite DX Digital Pathology Software is the device name listed in this FDA 510(k) record. The listed applicant is Jellox Biotech, Inc.. It received FDA 510(k) clearance on 2024-10-28 under 510(k) number K240303. The device is classified under product code QKQ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MetaLite DX Digital Pathology Software?

MetaLite DX Digital Pathology Software is a medical device that received FDA 510(k) clearance on 2024-10-28. The listed applicant is Jellox Biotech, Inc.. The 510(k) number is K240303.

When did MetaLite DX Digital Pathology Software receive FDA 510(k) clearance?

MetaLite DX Digital Pathology Software received FDA 510(k) clearance on 2024-10-28, under 510(k) number K240303.

Who is the listed applicant for MetaLite DX Digital Pathology Software?

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

What is the FDA product code for MetaLite DX Digital Pathology Software?

The FDA product code for MetaLite DX Digital Pathology Software is QKQ.

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：QKQ）

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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