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FDA 510(k)

ProNephro AKI™ (NGAL)

K 號：K232761 · 2023-12-07

申請人Bioporto Diagnostic, Inc.
決定日期2023-12-07
產品代碼PIG
諮詢委員會CH
決定相當於

器材摘要

ProNephro AKI™ (NGAL) is the device name listed in this FDA 510(k) record. The listed applicant is Bioporto Diagnostic, Inc.. It received FDA 510(k) clearance on 2023-12-07 under 510(k) number K232761. The device is classified under product code PIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ProNephro AKI™ (NGAL)?

ProNephro AKI™ (NGAL) is a medical device that received FDA 510(k) clearance on 2023-12-07. The listed applicant is Bioporto Diagnostic, Inc.. The 510(k) number is K232761.

When did ProNephro AKI™ (NGAL) receive FDA 510(k) clearance?

ProNephro AKI™ (NGAL) received FDA 510(k) clearance on 2023-12-07, under 510(k) number K232761.

Who is the listed applicant for ProNephro AKI™ (NGAL)?

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

What is the FDA product code for ProNephro AKI™ (NGAL)?

The FDA product code for ProNephro AKI™ (NGAL) is PIG.

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：PIG）

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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官方來源

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