FDA 510(k)

PhenoMATRIX

K 號：K251511 · 2026-01-22

決定日期2026-01-22

產品代碼PPU

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

PhenoMATRIX is the device name listed in this FDA 510(k) record. The listed applicant is Copan Wasp Srl. It received FDA 510(k) clearance on 2026-01-22 under 510(k) number K251511. The device is classified under product code PPU. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PhenoMATRIX?

PhenoMATRIX is a medical device that received FDA 510(k) clearance on 2026-01-22. The listed applicant is Copan Wasp Srl. The 510(k) number is K251511.

When did PhenoMATRIX receive FDA 510(k) clearance?

PhenoMATRIX received FDA 510(k) clearance on 2026-01-22, under 510(k) number K251511.

Who is the listed applicant for PhenoMATRIX?

The FDA 510(k) record lists Copan Wasp Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PhenoMATRIX?

The FDA product code for PhenoMATRIX is PPU.

其他以 Copan Wasp Srl 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。

K232756科利比 K223245科利比 K220546科利比系統 K193138Colibri 系統

相關器械（代碼：PPU）

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。

K183648APAS Independence 內建尿檢模組Clever Culture Systems AG

官方來源

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